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TdBACCO INDUSTRY RESI:ARCH 'COMMITTEE *350 FIFTH AVENUE ~ NEW YORK%1, N. Y: ' Application °For Research Grant - . ,..~_ & Address •._ Co7:tirabia'`iTn~~rersJ.ty"" '" # ~' `~Co].urrib3a ~tJniverszty ' ` ~ k~ b7.~ c Health '7?ro ject choo~. of r.i. g~eau of Applied Eocial Research ~ 600 West 168th Str.eet ~aT~d) T~ ,_ ._._..... Office h 427 West`' 11.7th Street - ~"ew• Yor1s- 32~ New York Ne`ii fo°k ~7 " ~New ~York ' 4: Proiect or Sub'iect: ;aA 5. Detailed Plan of Procedure -(Use- reverse side if additional pace is needed): The Division of Epidemiology of the SchooL of Public Health and the Bureau of Applied Social Research,, both of Columbia Universi-~y,- are- cnrrently *engaged in deyrel.oping a. design for a long term study of th.e- natural history o_~ Hyper,te,lnsio.n. The purpose o~a the study is to obtain, insight into tlie~ orig~.n9:. d.eve.].opment a~.d, sustenance, of ,Hypertens.ion,• th,rough`- •~ maka.ng frequent observations on a"normal" population over a long period of time. The study°of natural hi.story from an epidemiologic~ and preventive aspect goes beyond the study . ._ , _ .. .. ,...., .... , . . , t . of ~ pathogenesis ,and the course of a disease i~ ari indivi:diiala althoug}•;i •'a knowledge" of•-tiiis bourse- is esserati.al to' it. "If all of~ the e3.emien.ts' of causa.~2oi~ are to be taken' a.n.to ac;- couxit~ natural .history-iniist eXterxd ihto the' erviron~nerit and atnong the. assoeiates of the affected individual. It must- not overlook anc'~'estx*y, physical and keh.tal developmen.t~ associated `disease- agen;ts anc3. occupat~.on. "' Th~ts,' 'the° natura~. h~s`~ory of HypertEnsion would define ° the progress o-of ,his da.sorc3er'° begirini n~g' with° thehver~ first fore~e's`that ~i.naug~tzrate it in the environment,,r or elsewhere, through the resulting changes that take place in man and until equilibriumm is reached `or defeet,, da; s"ability or death `ensues. E _ _ . .. ,. The current work is being carried on •und6r the auspices 'of the. Recess Conudssa.on on . . . Hypertension of the Comi;n.onwealth-of Massactiazss'+,ts. The, idea of a longm term study developed from recomnendat~.ons made by leading investig~~tors during a two day Symposium (~1)1 held in February 19~1~ by the Commission. It seemed caear to ~axs ~ymposiu~a; that~xithou~ ef~`or; _ was being made in the laboratoxy ano. in~'the c~linic •to- answer questions susceptible to re- search ~n these qu.a.rters' the most signif9.can~~ gaps related to the degree of association between the • levels of b3.ood pressure.,; on -the. <i,ne. hand.,. and avariety f of personal and en- vironmental factors commonly thought - to:• be et:i:ologica.lly signif3:cant® Itd was„ suggested` that data on the physical-social and environm~i~iatal factors in relation to blood pressure 'alterations over a lorig peri.od;'bb collected hy means of appropriate epidemiological field Nrztnbers in parentheses refer to the Bibliogri~.phy attached. 3- Institution Health ~ ., ~ i~. . a x ,a 2. Title: (a) Professor of Epidemiology, Colunibia UniVers3.ty., School of- Public Health (b) Dz~ector~~ Bureau of Applied BocI _al Researchy Columbza University : ~c k ~ ssocaate Profe'ssoto~ &pJ.dema oj~ogy~` "~ofu~ia ~TriiversatY' _Sehoo~o~ : blic „ (b)- Charles Y. wGlock~ Ph:D., rc)' Robe'rt'L Vou h~ M D 1. Name of Investigator: ,.tta.). E. Giirney_ Clax!k.NLD..~ V . :«

i through utilization of methodological devices developed in the course of the pre•vious literature reviec~si which have been reported (5). As we see it,, literaturee reviews must be something more than a recitation of investigatorst results and cos.clusions. They must attempt to analyze .%~-the research design on which results are based and to interpret those results within '~he experimental fraznework: .~ A" r'eview -iriust also examine to what extent•results:can be projected outside:of the research design; and~ fi.nalLy-d.t must include posn,tiwe "suggestion•s as to -ho1W to 'dvercome ,,•the methodological'difficulties which~are=crit~.cited: . .. .. . .. h eses to be Tnc g , orporated )into the -Zon II_•. Selection of,.the , t rinci.pal ;Hypo~ Term:•Study.,,•Hypotheses eli_ citedom literature =reviews -are mast •, ._r.equently of a-type which 4suggeMst ~th_ at~hypertension as ;associated- with some concuxrent~.yi ol,aserved fac,tor Aor, phenomei2on~.? e.g.+' vascular hyper= reactivity or a,,pa:rticular :personal~.t£y conflict, Preliminary decisions as to which hypqthesesr t,o 3:.ncl,ud~ ~z the long term study will be made on ~the•basis of criteria ~hich-have`been developed in the projeet. These criteria involve the measurability of the associated phenomenon or factor and the specificitys coxzsistencyi, and persistence..-of the ;ass,oci~ation. We sha.lzl.1 still be faced -with the problem as to whether these hypotheses - can be tested-in a long term stvc1y because of problems of sam,ple -se7:ec- tion and size, or -because• of measurein,ent' techniques to be employed. .. ., . ..._- ..., __ .... . ... -t h. .. .~. ..-...,,...._ -..y •Bf ~etailed,:Plan, of Procedv.re (continued) studi.es'_ over }long..periods of time: testing: he work w.hich we are undertak3.ng to develop ~the., deszgn • of, a lor~g term study of the T natura7.. Yiistozy; of Iiyperten.siori, then, involves three. aconsecutive phases of liypo.thesis _ ~A mspecifi.catson of tYie data to beF~co~ ected"and of procedia:res for` The designf of the. -sample, a..e.j a~descripta.on of-.the.,principaL. ,-. characteristics of the population ~group . or••groups to- .be . studied over. .. .. the time`period and a plan for theb selection of the population sample. ~, -The i3evelopment of plAns for the c~z~alysis of the resu:~s. . ~ , ., , . -.. . . -. , _,.. . .. , .. , ; :_ .. ,._ __ ,. ,.,... . . For" the sceomplishriient of phases A. ~a critical" review ^of existing research findungs"ys 'requiredi 'fihereforetcra'ta:cal hteiature 'revi.ews are being. done 'ih fields , wYier6 there ar'e si.iggestion`s of -an association bs;tra'een specific ""factors' ahd in.itiatio3i or susterianee of _-Hypertension. "These reviews "comprise the fol].owaxigg sub jects :'.- the phenoinenon ,,:. of vascial.ar reactiv3ty~ :blood pre'ssure in:easiirement~ 'psycho7.ogical factors, soci©log'ical'- factors, nutritiori; constitution `and hereditypxiedical and physi.ologieal aspects of Hyper= - : . tensyon, 4 ~-The survey, of the fol7.owing• areas has been Fcompleted: • blood pressure~ measurement (10), vasou~ar reactivity (7)~ p.sychological factors (8)., sociological factors (ll)3' constitution (13). - Two field studies (9, 12) directed towar(~, the •,resolution of some of -the measurement problem$ raised by the suy o~ the la terature in thea areas o-f, hyperreacti~uity and blood - . ._k.R77 _. . . . ,r . _ . . c . ~~ The following remarks outline the specific'isteps which still need to be undertaken to execute the design of the long term study: ~. I. Completion of the literature reviews in the medical,~ nutrition and heredity _fields.,.. 'I'!?.e,accomplisunent of this work _w-ill be expedited re meas~rement have a7so been completed, ; press~ To cope with questions of this k~ind.we intend to consult with specialists in the areas of statistics' carcia.ovascular diseases, gen.etics' etc. On the basis , of their advice; t~ deciaii"o'ris : as* ~:to the hypothesis to be tested and sample selection-wi7.l be fifialitied..' (Detailed Plan concluded.on last page of the form) .

6. Budget Plan: 7. Anticipated Duration of Work: Te~a ~10). m.oriths 8. Facilities and Staff'Available: ` _....~..~~._ $05022.00 The_ pro ject wil l be' oonducted . as ajoa.nt c~perat~.on of the Division of Epidemiology~ School of Public Health~ an,d the Bureau of, App]riecl Social~,Recea~cYi~ - Columbia University. The facilities of.these institutions are avail2~lile to the Project. The Division of Epi- demiology is a part of the Columbia University ~Facul.ty of Medicine and as such has access to the professional fac3.,lities of the Columbia I Presbyterian Hospital; technical advice }.. and assistance is available through the Departrttents of Medicine~ Physiology' Biophysics, etc. The Bureau of Applied Bocial Research is the research ar.m.of the University in the social,sciences,, staffed,by a group„of approximately thirty professional and forty non- profe~s~i~nal ersonnefl.. The-'project would be authorized to ca7.7l on the staff of the Bureau rtional~teqwremen s: , for advice and guidance in carrying on the research. NONE 10. Additional Information (Incl;uding relation of work to other piIojects and other sources of supply): During its 1954 session' the General Court~[of Massachusetts (Legislature) extended the life of the Recess Comraissi.on until January lp 19,56. The balance of the grant for this project made in the 1952 session is .$6,a000' as of November h 1954. Thus the net amount needed (as shown"above) is $25s322.00Q I It shoul:d:be pointed out-that` the Division; of Epidem:i.ology and the Bureau of Applied Social Research make substantial contributions to this project in the fo,z3nm of salaries.9 equipment~ and office space. Total $24, 966.00 '. 1s000.00 500,00 3, 6.00 1,500.00 ~31,322.00 Balance', in Re.cess _ Comn:i,.ss3.on Gran ,000.00 - - - ~~--.- . ... - . , ~ ~ 'Amount Ued:ed• I The suggestion that this project be submitted to the TIRC came from within the tobacoo industry as a result of the paper (5), Tobacco Blood Pressure and Hypertension which brought out some of the methodological di7fies in this.area r_ ... ~_ Business Officer of the Institution

5. Detailed Plan of Procedure (concluded) =-`-'---TII. The Design of the Sampler. T~is phase involves the specification of the population group or grou~as ~nich are to be stut3ied. The group to be studied will have to.fulfill~,req,uirements which: 1) grow out of the nature of the hypotheses to be 'tes'ted and 2) derive,~from plans for the - ~° analys~s of the data obtaine'd® At this point, continuous statistical consultation will be necessairly® ~ ° 3Vo Preparation-of a Com.prehensive Stu Desi . The product of our work will .be embodied in a comprel'iensive docTUnent which wil1. -outline the proposed long term study of Hypertension. It willl include a statement of hypptheses which are to bO; tested; a].isting of "d.ata. to be collected and a statement of how they e~an be collected; the samp-le, design; a plan for the concurrent and final analysis of results. Very likel.y, preliminary field studies -or pilot testing will be •required;- - Research ciesiCgris for - such studies" wi1.l% be outlined. `e -

BIBLIaGRAPHY ~ 1, A Symposiixm on Essential erte.nsion. AhEpidemiologi.c Approach. ~ The Comr~onwealth .of MassachusEstts, Wri~ht and Potter~ Boston .1951. ~_. ~'~ 2, A Proposal for a Long Term Commxmty Aesearch in the gpidem3.ology of r Hypertension, Robert K. Mertoin, John A. Morse7.1l and E. Gurney Clark, a.bid. a P• 327. . . ~. . . ~ 3, An demiologic Approach to thel_ Study of High Blood Pressure. E. ,Gur.aey Clark, .M.D., .Dr.~ g.H,l F..~.P.H.A.., .F.A.C.P, yand John Morsell~ Ph.D.' Am: Jour. Pu.b d Health, 42 :542. .. .~'~ , ?c-~ 4. A Biblio ra h of the World Lit(3rature on Blood Pressures 1920-1950. µ 3.vols. ) .. Eda.ted by .Ernest K. Koller and Jacob Katz. The',Common- wealth of Massachusetts, Wrij~ht.and Potter, BostAn 1952. * 5* Statistical ll Association,= February 1954. ) ._ Tobacco, Blood Pressure and BYPartension. R. L. Vought, M.D.j and ,.'E. Gurney,Clark, .M.D. (Read, ait New York State Chapter, American ~ 6. An Epidemti.ological A~ _ r~ oach to ~,he Study of Hypertension. R. L. , Vought, M.D,' and:E. Gurney CLark, M.D®(Read at the.American E,pidemi,ological Society, Clevi ~land, Apri ~. 1954.) 7. OnI the Phenomenon'of Vascular H, ~~erreaotiv3ty. R. L. Vought, M,D., .B.A. _ ; ^,and •E0 K. Koller, * 8. The Role bf Psychologi.cal Facto;rs in Hypertension. Henry L. Lennard ,. .aand Charles Y. G ock. .(ftead at the. American .Psychological Associ- ation, 'New .Yor33, September 195,14. ) 9. Toward a Standard Method of Blood Pressure Measurement. (Based on a field study of 21 nteers for an l day period.) R. L. Vought, M.D.., and C. Y. Glock, Ph.D. ; 10, On the Measurement of Blood Prefssure, Jacob Katz. 1.1, Sociolo3.g,ca1 Factors in ert nsion. H.•L. Lennard. ~ 12. A Com f arison of Tests for Vasc-u.lar Hyperreactiva.ty, f Based on a ~ ield tudy of , 200 volu~iteerg~, j~ .. 13. Constitutiorial Factors ~'`* Published. * Publication due early in 1955. 10254 ertensions Jacob Katz.