EPIDEMIOLOGY PERSPECTIVE IN NURSING Prepared by: Anna Liza R. Alfonso RN, RM, MAN LEARNING OBJECTIVES: 1.

Determines traits of successful clinical epidemiology researc er !. "dentifies preparation, protocols, collection , analyzing of researc #. Determine $no%ledge on t e preparation of reports, publication researc result dealing %it t e press

UNIT 3 EDUCATION & TRAINING IN CLINICAL EPIDEMIOLOGICAL RESEARCH: TRAITS OF SUCCESSFUL CLINICAL EPIDEMIOLOGY RESEARCHER EPIDEMIOLOGY &cientific study of epidemics, implicitly communicable disease &tudy of t e distribution and determinants of ealt related states and e'ents in populations and t e application of t is study to control ealt problems.

CLINICAL EPIDEMIOLOGY (irst used )* years ago by +o n R. Paul % o defined it as ,a marriage bet%een -uantitati'e concepts used by t e epidemiologists to study disease in populations and decision.ma$ing in t e indi'idual case % ic is t e daily fare of clinical medicine/ 0it implies that clinician should consider the facts derived from population-based studies of clinical conditions before deciding what to do about individual patients.1 2 e science of ma$ing PREDICTIONS ABOUT INDIVIDUAL PATIENTS by counting clinical e'ents in similar patients, using strong scientific met ods for studies of groups of patients to ensure t e prediction are accurate 3sed as aid to clinical decision ma$ing.

PURPOSES OF CLINICAL EPIDEMIOLOGY 2raditional basic sciences 0pat op ysiology, p armacology, etc.1 do not incorporate t e uncertainties of medicine 2raditional clinical approac es do not formally consider t e conte4t of disease 0or ealt 1 in a population 2raditional clinical approac es do not encourage assigning patients into ,crude ,categories of ris$ % ic allo%s for t e detection of association bet%een ris$ factors and outcomes in populations

2 e associations found in populations may be rele'ant to indi'idual patients

How is cli ic!l "#i$"%iolo&' (s"$) 2est ypot eses generated by t e basic sciences 0etiology, diagnosis, treatment1 in researc studies Assess researc reports in t e literature Assess clinical and population data

T'#"s o* +("s,io s !$$-"ss"$ .' cli ic!l "#i$"%iolo&' Abnormality 5 Diagnosis 5 (re-uency 5 Ris$ 5 Prognosis O(,co%"s o* cli ic!l "#i$"%iolo&ic s,($i"s 5 Deat 5 Disease 5 Discomfort M",/o$s o* cli ic!l "#i$"%iolo&' 1. Formulate Question (Hypothesis) 5 7lements of a good -uestion 0 ypot esis1 8 2arget population 8 2arget e4posure 0ris$ factor, protecti'e factor, treatment1 and its control 8 &pecified outcome 8 74ample: "n adults is ypertension associated %it an increased ris$ of coronary artery disease9 0 C-i,"-i! *o- ! &oo$ +("s,io 8 Ne% information9 8 (easible to ans%er9 8 Public ealt importance9 2. Choose Study Design A1 E2#"-i%" ,!l 0e.g. randomized, controlled trial 0R621 5 Randomly assign ,e4posure/ 0usually an inter'ention1 to study population 5 Measure ,outcome/ during some follo%.up period 5 :est met od to eliminate selection bias 0re-uired for p armacologic treatment by (DA1 5 ;o%e'er 8 &ome e4posures cannot be randomly allocated 5 Disability 5 Dissatisfaction 5 2reatment 5 Pre'ention 5 6ause 5 6ost

8 &election criteria may limit generalizability 8 ;ig cost B1 O.s"-3!,io !l: 45 Co/o-, s,($' . 6lassify indi'iduals in study population into ,e4posure/ categories 5 Measure ,outcome/ during some follo%.up period 5 6an be retrospecti'e or prospecti'e 5 (easible for common outcomes, less costly t an R62s 5 ;o%e'er 8 &ub<ect to selection bias 8 Among obser'ational study designs most costly 8 Not feasible for rare outcomes 65 C!s"7co ,-ol s,($' 5 6 oose a sample of indi'iduals %it t e ,outcome/ of interest 0cases1 and a sample of indi'iduals %it out t e ,outcome/ 0controls1 5 Assess ,e4posure/ status of study population sometimes in t e past 5 Retrospecti'e e4cept for nested case.control studies, i.e. % en case and control sub<ects are dra%n from a co ort study 5 Ad'antages: less costly, appropriate for rare outcomes 5 Disad'antages: more sub<ect to bias 35 C-osss"c,io !l s,($' 5 Also called a pre'alence study 5 Assess ,e4posure/ and ,outcome/ of study population at t e same time Ad'antage: least e4pensi'e of obser'ational studies 5 Disad'antage: no temporal relations ip bet%een ,e4posure/ and ,outcome 3. Choose Study Population Base and Sample rom that Base 5 &truggle bet%een access and generalizability 5 Population :ase c oices include 8 Acti'e patients 0clinic= ospital1 8 6ommunity residents 0geograp ic1 8 6ombination 5 &ampling c oices include 8 Random sampling 8 &tratified random sampling 8 6on'enience sampling 5 Depends on study design !. "nalysis o epidemiologi# studies 5 &ensiti'ity and specificity in studies of diagnostic tests

5 Relati'e ris$ and odds ratios in studies of association bet%een ris$ factors and outcomes PREPARATIONS ON RESEARCH PROTOCOLS PROTOCOLS >protocol> is defined as a complete %ritten description of, and scientific rationale for, a researc acti'ity in'ol'ing uman sub<ects. >protocol> means bot t e %ritten description of t e researc acti'ity and t e acti'ity itself. PREPARATIONS ON RESEARCH PROTOCOLS ?;@ . A carefully planned protocol is a prere-uisite for preparing any successful researc pro<ect. A sur'ey of t e literature s ould elp to put t e ob<ecti'e of t e pro<ect into s arp focus. A %or$ing ypot esis is t en formulated and t e e4perimental approac to test t is ypot esis is designed. 2 e met ods necessary to gat er t e rele'ant data must, o%e'er, be e4ecuted %it due consideration for t e et ical aspects t at go'ern e4periments on bot animals and uman sub<ects.

8RITING A PROTOCOL 2 e protocol of t e study s ould be %ritten according to t e specifications of t e funding body. Alt oug t e layout of t e application forms 'aries from one funding body to anot er, t ey are generally di'ided into t e follo%ing sections: Study hypotheses $ 2 e main and secondary study ypot eses s ould be %ritten in a clear and concise %ay, indicating t e e4posure0s1 and outcome0s1 of interest and t e magnitude of t e anticipated effect0s1. Ba#%ground and &usti i#ation $ 2 is section s ould include a brief re'ie% of t e state of $no%ledge about t e topic. "t s ould A<ustifyB t e need for t e proposed study by clearly indicating its originality and t e potential significance of its findings. 2 e proposed researc may be a logical e4tension of pre'ious %or$ conducted by t e researc ers or of an initial pilot study. 2 e results of suc studies s ould be presented ere. Study population and methods o re#ruitment$ 2 e geograp ical location and t e demograp ic c aracteristics of t e study population s ould be described. Any particular reasons for t e c oice of t e study population s ould also be gi'en. (or instance, a particular study population may a'e been c osen because of its e4ceptionally ig e4posure to a particular ris$ factor or for logistic reasons suc as ease of follo%.up. Details s ould be gi'en on o% t e study sub<ects %ill be recruited. Study design $ "t must be made e4plicit % et er t is %ill be an inter'ention, co ort, case8 control, cross.sectional or routine.data.based study. 2 e c oice of design needs to be <ustified Sample si'e $ "t is necessary to s o% t at t e proposed number of sub<ects in t e study %ill pro'ide ade-uate po%er or precision to detect or estimate a particular effect. &ample size

estimates s ould be presented under different assumptions. A single estimate is rarely con'incing. (ethods o data #olle#tion $ 2 e met ods of data collection 0e.g., inter'ie%, laboratory measurements, e4traction of data from clinical records, etc.1 s ould be described in sufficient detail to s o% t at t e plan as been ade-uately prepared and is feasible. Possible practical constraints and strategies to o'ercome t em s ould be presented ere. Statisti#al analysis$ A concise description of t e statistical met ods planned for use in t e analysis of data s ould be gi'en. )thi#s $ 2 e protocol of any study in'ol'ing uman sub<ects s ould pro'ide ans%ers to t e follo%ing -uestions: ? at %ill t e sub<ects be told9 ? at %ill t eir collaboration entail9 ?ill in'asi'e procedures be used9 Are t ere any ris$s for participants9 ;o% %ill consent be obtained 0e.g., at an indi'idual or community le'elC %ritten or 'erbal19 ? at steps %ill be ta$en to ensure confidentiality of t e data9 "t %ill be %ort consulting at t is stage t e et ical guidelines proposed by t e 6ouncil for "nternational @rganizations of Medical &ciences (CIOMS) and the World ealth Organi!ation (W O) ("##$). Most funding bodies will fund onl% pro&ects that have been approved b% the relevant ethical committees and some will wish to see samples of the information sheet and consent form to be given to the stud% sub&ects. *imeta+le $ A realistic timetable for carrying out t e 'arious acti'ities of t e study s ould be pro'ided. 2 is s ould incorporate milestones to be ac ie'ed at regular time inter'als 0e.g., e'ery si4 mont s1, % ic %ill elp in monitoring t e progress of t e study. ,e eren#es$ to $ey publications s ould be included in t e grant proposal. Designing, planning and conducting epidemiological researc Budget $ 2 e budget is generally di'ided "nto staff costs, e-uipment 0e.g., computers, freezers, centrifuges1 and running e4penses 0e.g., office e4penses, computer and laboratory consumables, tra'el costs1. 7ac item must be <ustified and of reasonable cost. 2 is %ill often in'ol'e discussions %it t e personnel office about staff costs and consulting price lists to get t e best prices for supplies and e-uipment. "n certain countries, allo%ances s ould be made for inflation and currency fluctuations % en calculating t e final budget. "t is also important to c ec$ % et er t e institution % ere t e study is going to be based %ill c arge Ao'er eadsB. 2 ese correspond to t e costs to t e institution of administering t e grant, organizing t e payment of salaries, ordering supplies, pro'iding office space, eat, electricity, air.conditioning etc. &ome funding bodies refuse payment of o'er eads 0e.g., t e ?orld ;ealt @rganization1, % ereas ot ers %ill pay only up to a certain proportion of t e total cost 0e.g., t e 7uropean 6ommission pays only !*Dof t e total cost1. "f t e funding body does not pay o'er eads, it may be possible to include as running costs in t e budget some e4penses t at mig t ot er%ise be co'ered by t e o'er eads, suc as telep one, fa4 and mailing costs.

Dissemination o results 7 &ome funding bodies re-uire applicants to state o% t ey intend to inform study participants about t e findings of t e study and o% t ey %ill be disseminated to rele'ant ealt aut orities and t e scientific community 2 e in'estigator s ould also inform all people % ose appro'al or cooperation is eit er re-uired or desirable. Proposed researc in clinical or academic institutions s ould be presented to appropriate departmental eads and=or ospital administrators. @ften t ere %ill be a committee specially designated to re'ie% and appro'e study protocols. &tudies conducted in t e community s ould be presented to local ealt officials. "n addition to gaining t e re-uired appro'al, t e in'estigator may recei'e 'aluable practical suggestions and ot er assistance from t ese indi'iduals, suc as introductions to p ysicians % o may permit t e study of t eir o%n patients. 2 e in'estigator may also learn of ot er similar or related researc t at isunder %ay. 6ooperation %it ot er in'estigators may elp a'oid duplication of effort and lead to s aring of resources and, possibly, e'en of data.