Table Of Content

InternationalJournalofTechnologyAssessmentinHealthCare,29:2(2013),166–173. (cid:2)c CambridgeUniversityPress2013.TheonlineversionofthisarticleispublishedwithinanOpenAccessenvironmentsubjecttotheconditionsoftheCreativeCommonsAttribution- NonCommercial-ShareAlikelicence<http://creativecommons.org/licenses/by-nc-sa/3.0/>.ThewrittenpermissionofCambridgeUniversityPressmustbeobtainedforcommercialre-use. doi:10.1017/S0266462313000020 Quality indicators to assess a colorectal cancer prevention program VictoriaSerra-Sutton MireiaEspallarguesCarreras Catalan Agency of Health Information, Assessment and Quality, CIBER Epidemiolog´ıa CatalanAgencyofHealthInformation,AssessmentandQualityandCIBEREpidemiolog´ıay ySaludPu´blicaBarcelona SaludPu´blicaBarcelona CarmelaBarrantesSerrano UniversityHospitalVallHebroń,PreventiveMedicineServiceBarcelona(Spain) Objectives:Theaimofthisstudywastoimplementasetofindicatorstoassessthequalityofcareofanewhealthcaremodelforpreventionofcolorectalcancerinahigh-risk population. Methods:Informationwasobtainedretrospectivelyfromelectronicclinicalrecords,reviewofdocumentation,andasurvey.Thehigh-riskclinicforcolorectalcancerwascreatedin Barcelona(Spain)in2006.Allusersatgreaterriskofcolorectalcancerassessedthroughthenewhealthcaremodelwereincluded.Twenty-oneindicatorswerecomputedusing definedformulasandstandards.Logisticregressionmodelswerecomputedtoanalyzefactorsrelatedtoadherencetothescreeningandsurveillancepreventionstrategies. Results:Atotalof1,275userswereincluded.Eightofseventeenindicatorsreachedthequalitystandard(80percentstructure,50percentprocess,and17percentoutcome), whereasfourindicatorsdidnothaveapreviouslydefinedstandard.Theoveralladherencetothescreeningandsurveillanceprogramwas67percent.Usersaged59andolderhad almosttwotimesgreaterprobabiblity(95percentconfidenceinterval[CI],1.3–3.1)ofadherencethanyoungerusers;userswithsurveillancecolonoscopiespresenteda7.4times (95percentCI,4.6–11.7)greaterprobabilityofadherencethanthosewithscreeningcolonoscopies. Conclusions:Theindicatorshavebeenshowntobefeasibleandvalidtoolstoidentifyareasofimprovementinthisnewmodel,suchasinformationsystems,continuityofcare,and communicationamongprofessionals.Becausethiswasthefirsttimetheseindicatorswereappliedtoassessthehigh-riskclinicforcolorectalcancer,furtherimplementationis requiredtoimprovetheinterpretabilityofresults. Keywords:Qualityindicators,Colorectalcancer,Healthtechnologyassessment,Adherence,Preventivemedicine Most prevention programs for colorectal cancer (CRC) are touspolyps.Individualsinthegroupofcarriersofmutationsin aimed at medium-risk populations and are included in specificgenesrepresentbetween3percentand5percentofall population-basedpreventionstrategies.Themaininclusioncri- patientsdiagnosedwithCRC. teria in this type of program is age (aged 50 and older without In2006,theHigh-RiskClinicforColorectalCancer(HRC- personal or family history of colorectal adenomas or CRC) CRC)(3;4),anewhealthcaremodelforthepreventionofCRC (1,2). There is another risk group, made up generally of indi- in a high-risk population, was created at the Hospital Clinic viduals at increased risk of developing CRC, which includes the following criteria: (i) individuals who carry mutations in certaingenes,(ii)individualswithafamilyhistoryofCRC,and (iii)individualswithahistoryofhigh-riskcolorectaladenoma- herhelpinreviewingthedatabaseandindefiningthecomplexsyntaxforcreatingvariables; AntoniParadaforhisexhaustiveliteraturesearchestoidentifysimilarstudiesthatalsoassessed TheresearchteamthanksAntoniCastells,directoroftheInstituteofDigestiveandMetabolic models/programsforthepreventionofCRCinpopulationsathighriskbasedonindicators;and DisordersattheHospitalClinicdeBarcelona,forhiscollaborationincollectingandcategorizing OlgaMartinezforherhelpinfieldwork.Finally,wethankElenaDopinofortheeditingofthefinal studyvariables,forhisinputintothehealthcaremodeloftheHighRiskClinicforColorectal Englishmanuscript.ThisprojectwaspartiallyfundedbytheQualityPlanoftheSpanishMinistry Cancer(HRC-CRC),forhishelpinidentifyingriskprofilesofusers,andforhiscommentsona ofHealth2009andalsoconstitutesatechnicalconsultationfromtheCatalanDepartmentof previousversionofthismanuscript.WealsothankMariaPelliceandTeresaOcanãfromthe Health.CarmelaBarrantesSerranoisaresidentofPreventionMedicineandPublicHealthatthe GastroenterologyServicefortheirhelpinrecodingvariablesandforprovidingthenecessary VallHebronUniversityHospitalinBarcelona.ThisarticleispartofherMasterofPublicHealth informationforthecollectionofdataforsomeindicators.OurthanksalsogotoMontserratMila`, thesisdefendedinSeptember2010atthePompeuFabraUniversity.Wearealsogratefulto ImmaGarrell,JosepMariaPeri,LeticiaMoreira,MariaDoloresGira´ldez,MiriamCuatrecases, CarmeBorrellandAndreuSeguraasevaluatorsofthethesisresearchprotocol,whichimproved SergiCastellvi-Bel,andMar´ıaLo´pez-Ceroń,fortheircollaborationintheproject.FromtheCatalan thefeasibilityoftheproposeddissertationanditsmethodologicaljustification.Wealsothank AgencyforHealthInformation,AssessmentandQuality,wealsothankSilviaLopezAguilarfor XavierCastellsforhiscommentsonadraftdocumentasathesisevaluatorbeforefinaldefense. 166 Qualityindicatorsforcolorectalcancer of Barcelona under the coordination of the Institute of Diges- ofcareofaCRCpreventionprograminahigh-riskpopulation tiveandMetabolicDisorders.TheHospitalClinicofBarcelona taking into account all the healthcare processes involved. The is a reference, community, level 1, public teaching hospital in primaryobjectiveofthisstudywastoimplementasetofindi- Catalonia with renowned capabilities, both nationally and in- cators to assess the quality of care of a new healthcare model ternationally, in healthcare, research, innovation, and quality forthepreventionofcolorectalcancerinahigh-riskpopulation teaching.Cataloniaisoneoftheseventeenautonomousregions (at baseline and independently). Furthermore, as a secondary inSpainwitharegionaladministrationandautonomousgovern- objective,factorsrelatedtoadherencetoscreeningandsurveil- mentandparliament.TheHRC-CRCwasfundedbytheCatalan lance prevention strategies in this model were analyzed. Sev- DepartmentofHealthwiththeaimofimplementingprevention eral studies have evidenced that demographic factors such as strategies in populations at greater risk of CRC (individuals user gender, age, and health status are related to their adher- withahereditaryorindividualpredispositiontocolorectalcan- ence to screening and surveillance prevention strategies (6;7). cer such as Lynch syndrome, familial adenomatous polyposis, The assessment of factors relating to adherence to this type of or advanced colorectal adenomas). The HRC-CRC is staffed strategies in the HRC-CRC was considered relevant to assess with health professionals from the fields of gastroenterology, the construct validity of three proposed indicators measuring biochemistry and molecular genetics, pathology, clinical psy- patient-centeredcare. chology, nursing, gastrointestinal surgery, oncology, and family and community medicine. The roles of this new healthcare METHODS model/programincludedthefollowingmainareasofhealthcare: Aretrospectiveobservationalanddescriptivestudywascarried (i) to identify individuals at increased risk of developing CRC out. The study population included all users assessed at the (mainly individuals referred from primary health care accord- HRC-CRC between January 1, 2006, and May 12, 2010. Pa- ing to evidence-based criteria in relation to CRC risk factors tients with advanced colorectal adenoma, hereditary polyposis of increased risk or other specialized services from their own syndromes, CRC, and healthy users at increased risk (family hospital or from other hospitals;patientsand users also access members of patients with CRC or hereditary syndromes) aged the program on their own initiative; (ii) to establish the risk of 18andolderwereincludedinthisstudy(3;4). CRC in users with personal risk factors and/or a family history of CRC; (iii) to propose the most appropriate screening andsurveillancepreventionstrategies;(iv)tocarryoutgenetic DevelopmentofQualityIndicators counselinginhereditaryformsofCRC,genetictesting,andpsy- In a previous study, thirty indicators were developed to as- chological assessment; (5) to carry out additional endoscopic sess the quality of care of the HRC-CRC or other prevention and radiological procedures for prevention, diagnostic; and/or programs in Catalonia/Spain (8). A conceptual framework for therapeuticaims. the assessment of these programs and the definition of indica- In a first phase of implementation of the HRC-CRC, the torswasproposed.Thisframeworkincludedthemainactivities Hospital Clinic of Barcelona, pending the incorporation of a (process of care) of the new prevention program from the per- secondary hospital, assumed the role of secondary and ter- spective of Donabedian for quality assessment (including the tiary care provider, and was linked to two primary care cen- measureoftheimprovementofhealthservicesresultsandalso ters, which took on the primary level functions of this new thestructureandprocessofhealthcare).Fivedomainswerealso organizationalmodelforthepreventionofCRC.Tertiarylevel proposedintheframeworktomeasurethequalityofhealthcare functions of this model consist mainly in the implementation (clinicaleffectiveness,continuityofhealthcare,access,safety, of measures for genetic counseling and testing, and the per- andpatient-centeredcare). formance of complex surgical or endoscopic procedures (e.g., A literature review was performed to identify published Lynch syndrome). Secondary level functions include the man- studies that assessed CRC prevention programs in a high risk agement of high-risk forms of CRC requiring colonoscopies populationusingqualityindicatorsandtheirconceptualframe- withaperiodicityoflessthan5years(e.g.,familialCRC)and works.Twoconsensusmeetingswereheldwithtwelveexperts the performance of conventional and therapeutic endoscopic from the Hospital Clinic of Barcelona and the Hospital Costa procedures. Finally, functions at the primary care level consist del Sol in Malaga (including the fields of gastroenterology, inidentifyingpopulationsatgreaterriskofCRCandthefollow- nursing,primarycaremedicine,moleculargenetics,pathology, up of users on the prevention program with intervals of over 5 clinicalpsychology,medicaloncology,management,andhealth yearsbetweencolonoscopies(e.g.,patientswithnon-advanced servicesresearch).Expertswereaskedtoproposeindicatorsfol- adenomas). lowingtheabove-mentionedconceptualframework.Indicators Althoughtheactivities(clinicalpractice)oftheHRC-CRC were arranged in panels by the moderator of the consensus areevidence-based,tothebestofourknowledge,noassessment meeting (metaplan technique) according to the defined frame- ofthequalityofcareandthebenefits/riskofthepreventionpro- work. All proposed indicators were voted by the experts in a gram on the user’s health have been carried out (4;5). To date, final round. Stickers were placed on the indicators by each ex- nopublishedstudyhasbeenidentifiedthatevaluatesthequality pertwhendeemedimportantorfeasible.Twofocusgroupsthat 167 INTL.J.OFTECHNOLOGYASSESSMENTINHEALTHCARE29:2,2013 Serra-Suttonetal. included users from the HRC-CRC were also held to obtain indicators, clinical and management documentation was con- additional indicators that had not been mentioned by the ex- sulted.Additionalinformationwascollectedthroughquestion- perts. The research team developed cards for each indicator, nairessentbyemailtoprofessionalsorcollectedinface-to-face includingthetitleoftheindicator,formula,descriptionandjus- interviewsattheHRC-CRCbytheresearchteam. tification, sources of information to obtain the indicators, and qualitystandard. StatisticalAnalysis Finalconsensusofindicators(cards)wasdefinedbyapply- Twenty-oneindicatorswerecomputedaccordingtoapreviously ing the Delphi technique, with the participation of fifty-three defined formula, and results obtained were compared with de- experts from different centers, regions in the Spanish Health finedqualitystandards(0–100percent)(8).Forsomecomposite System, and the same multidisciplinary profiles included in indicators, global and partial compliance was described. Star consensus meetings. Experts were asked to vote on the impor- graphs were computed to present a visual differentiation be- tance and feasibility of (on a scale of 1 to 10, where 1 was tweenthedefinedqualitystandardandthelevelofcompliance. minimum and 10 was maximum) as well as their agreement Donabedian and other authors consider that outcomes of with each proposed indicator (fully agree, agree with modifi- health services are mainly related to the structure and process cations, or fully disagree) (8). Experts in this final consensus of healthcare as well as to patient/user characteristics (9;10). wereaskedtoproposeaqualitystandardforeachindicator(the To apply this perspective, the research team revised the pro- standardwascalculatedusingthemeanvalueobtainedfromall posed indicators and selected adherence to the screening and theexperts). surveillance prevention program as an outcome indicator for multivariate analysis. The reasons for selecting this indicator Indicators,Variables,andSourcesofInformationinthePhaseof weremainlyduetothefactthatitappliedtothemajorityofthe Implementation patients/usersassessedintheneworganizationalmodel(ensur- Before collecting the data to implement the indicators, the ing an effective number of cases in the numerator and denom- research team reviewed each indicator taking into account a inator of the formula to compute adherence). In addition, this preliminary revision of available data, the feasibility to cal- indicatorwasalsoconsideredanintermediate-termoutcome(in culate each indicator in the study schedule, simplicity of the contrastwiththeglobaleffectivenessoftheprogram[diagnosis formula computation, and those indicators that applied to the ofcolorectalcancerinearlystages],whichrepresentedasmall majority of the study population. Of the thirty proposed in- numberofcasesandneededalongerfollow-upperiodtoobtain dicators, twenty were selected for implementation and one a robust measurement). Most of the variables related to ad- additional indicator was proposed that included a compos- herence to screening and surveillance prevention strategies in ite of two previous indicators (global adherence to the pre- colorectalcancerusedinthepresentstudyhavebeenpreviously vention program-screening and surveillance colonoscopies); reportedinotherpublishedstudies. see Supplementary Material, which can be viewed online at To identify factors related to global adherence to screen- www.journals.cambridge.org/thc2013089(6). ing and surveillance prevention strategies, multiple regression The necessary information for calculating each indica- modelswerecomputedusingglobaladherenceasthedependent tor, together with user demographic and clinical variables variable and user demographic, health status, and healthcare at the HRC-CRC, were collected, including gender; age processfactorsthatshowedstatisticalsignificanceonbivariate (<45, 48–59, >59); type of prevention strategy (a) screening analysis(p<.05)orthosethatwerehypothesizedtobeconcep- colonoscopy, which suggests an examination of the colon, fol- tuallyrelevant(asdescribedpreviouslyinthevariablessection) lowing evidence-based clinical criteria; if abnormal areas are as independent variables. Each logistic model was adjusted by detected, tissue can be removed and examined to determine genderandagedifferences.TheSPSSpackagewasusedforthe if there is presence of disease; (b) surveillance colonoscopy, statisticalanalysis. whichsuggestsaperiodicalexaminationofthecolon,following evidence-based clinical criteria, after the detection or removal of disease in the colon)1; (c) personal risk at the moment of RESULTS inclusioninthestudy(advancedcolorectaladenoma,polyposis CharacteristicsofPatientsandUsersandSomeAspectsoftheHealthcare syndrome,CRC,healthyhigh-riskrelative);andsiteofreferral Process (otherhospitals,otherintra-hospitalservices,primarycare,and Theinitialdatabasecontainedinformationon1,607users;311 user’sowninitiative). users that had been included in the HRC-CRC before January Theprimarysourceofinformationforcalculatingthepro- 1,2006(dataatthestartofthenewhealthcaremodel),4users cessandoutcomeindicatorswastheinformation-basedclinical thatwereundertheageof18,and17userswithouthighriskof records of the HRC-CRC (Progeny). In the case of structure CRCinthedatabase,wereexcludedfromthestudy.Ofthetotal sample, 54 percent were women, and 34 percent were over the 1AdaptedfromdefinitionsincludedintheNationalCancerInstitute,http://www.cancer.gov ageof59(Table1).Inaddition,63.1percentofuserswereseen [consulted17/07/2012]. duetoafamilyhistoryofCRC(screeningpreventionstrategy), INTL.J.OFTECHNOLOGYASSESSMENTINHEALTHCARE29:2,2013 168 Qualityindicatorsforcolorectalcancer Table1. Demographic,HealthStatus,andProcessCharacteristicsofPatients ComplianceofIndicatorswithQualityStandards intheHRC-CRCinthePeriodfrom2006to2010(n=1,275) Structure indicators that reached the quality standard were: availabilityofinformation-basedclinicalrecordsintheprogram (100 percent), access to an accredited and certified molecular Variables N % genetics laboratory, and availability of prevention campaigns aimedatusersandpatientsintheHRC-CRC(100percent)(Fig- Gender ure1a).Eventhoughanevidence-basedprotocolandaclinical Women 692 54.3 practiceguidelinewere availableattheHRC-CRC, theindica- Men 583 45.7 torthatassessedtheexistenceofaclinicalprotocolreachedan Missingvalues — — overallcomplianceof73.9percent.Thespecificaspectsofthe Age protocolthatdidnotmeetqualitystandardswerethefailureto <45yearsold 385 30.2 include:allactivitieswithscientificevidence,algorithms(refer- 46–58yearsold 425 33.3 raltoclinicalpsychologyserviceormoleculargenetics),andthe >59yearsold 434 34.0 collaborationofallprofessionalprofilesinthedevelopmentof Missingvalues 31 — suchprotocol.Thelevelofimplementationoftheclinicalproto- Personalriskstatus colbyprofessionalsreachedacompliancelevelof83.3percent. Advancedcolorectaladenomaa 589 46.2 Figure1bshowscompliancelevelsachievedbytheprocess Polyposissyndromeb 107 8.4 indicators. The rate of users referred to the program was 43.0 Colorectalcancer 163 12.8 percentfromprimarycareand28.5percentfromotherin-patient Healthyrelativeathighriskc 416 32.6 departments or services (data not shown). On the other hand, Missingvalues — — 1.9percentofuserswithapossiblepolyposissyndromeneeding Endoscopicpreventionstrategy molecular genetic testing were referred to clinical psychology. Screening 805 63.1 InfamilieswithhereditaryCRCwithanassociatedknownmu- Surveillance 399 31.3 tation,apresymptomaticdiagnosisthroughgenetictestingwas Missingvalues 71 — carried out in 56 percent of relatives at risk. In relation to the Referraltothecoordinatingservice waitingtimetoobtaintheresultsofthegenetictest,33percent Fromprimarycare 548 43.0 of users who had undergone this test obtained the results 12 Intra-hospitalunits 363 28.5 monthsafterthetimeofrequest.Finally,regardingthecompre- Patient’sowninitiative 136 10.7 hension of the information given to users in the program, only Otherhospitals 45 3.5 19 percent had completed a comprehension questionnaire and Otherpreventionprograms 24 1.9 thesecorrespondedtouserswhohadbeenvisitedbythenurse Missingvalues 159 — intheprogram. Endoscopictestscarriedout Regarding outcome indicators, the rate of complications Includesbaselineandfollow-up 413 32.4 during colonoscopies was 0.6 percent (data not shown), while Onlyincludesbaseline 200 15.7 the rate of early-stage CRC diagnosis was 55.6 percent (as a Includesbaselinebutfollow-updoesnotapply 193 15.1 proxy of the global effectiveness of the program). Adherence Baselinedoesnotapply 408 32.0 toscreeningandsurveillancepreventionstrategiesachievedthe Missingvalues 61 — agreed standard for the surveillance strategy (mainly applied aLesions≥10mm,withvillouscomponentorhighgradedysplasia. to patients with advanced colorectal adenomas; 91.2 percent), whereasforthescreeningstrategy,thelevelofcompliancewas bMutationsincertaingenes. 51.7 percent, below the agreed quality standard (80 percent) cHealthy relative at risk: the user has been included in the HRC-CC but a (Figure1c).Thecompliancetoglobaladherencewas67.3per- polyposis syndrome or high-risk colorectal adenoma or CRC have not been cent.Usersatisfactionwiththecareprovidedwasmeasuredin identified. 19percentofthe599usersseenbetween2008and2010(period HRC-CC,high-riskclinicforcolorectalcancer. inwhichthecollectionofinformationstarted). Overall, eight of seventeen indicators reached the previ- ouslydefinedqualitystandard(80percentinthecaseofstruc- 46.2 percent presented a high-risk colorectal adenoma at the ture, 50 percent of process, and 17 percent of outcome indica- timeofthestudy,63.2percenthadhadatleastonecolonoscopy, tors).Moreover,4indicatorswerecomputedbutdidnothavea and32.4percenthadhadtwocolonoscopies(atbaselineandat previouslydefinedstandard.Whentakingintoaccountthequal- follow-up).Atotaloftwelveprofessionalsprovidedinformation itydomainmeasured,40percentoftheindicatorsthatmeasured on some indicators related to the quality of care in the HRC- clinicaleffectivenessachievedthestandard(2/5),100percentof CRC. theindicatorsthatmeasuredaccessibilityachievedthestandard 169 INTL.J.OFTECHNOLOGYASSESSMENTINHEALTHCARE29:2,2013 Serra-Suttonetal. (a) 1 100 90 80 5 1.a 70 60 50 40 30 20 10 4 0 1.b 3 1.c defined standard compliance level 2 (b) 6 100 90 80 70 11 5600 7 40 30 20 10 0 10 8 defined standard compliance level 9 (c) 12 100 90 80 70 17 5600 13 40 30 20 10 0 16 14 defined standard compliance level 15 Figure1. Levelofcomplianceofindicatorswithdefinedqualitystandards.a:Levelofcomplianceofstructureindicators.1.Availabilityofamultidisciplinaryclinicalevidence-basedprotocol;1a.Protocolwithrecommendations, decisiontools;1b.Protocolwithevidence-basedactivities;1c.Multidisciplinaryprofileofauthorsoftheprotocol;2.Accesstoacertifiedandaccreditedmoleculargenetictestinglaboratory;3.Availabilityofaside-viewing duodenoscopyforscreeningofpatientswithpolyposissyndrome;4.Availabilityofpreventionstrategiesofcolorectalcancerinahigh-riskpopulationforusersandpatients;5.Existenceofinformation-basedclinicalrecords. b:Levelofcomplianceofprocessindicators.6.Availabilityofacolonoscopyqualityprogram;7.Rateofindicationofdieteticandnutritionalneedsassessment;8.Levelofimplementationoftheclinicalprotocol;9. Presymptomaticdiagnosisofuserswithhereditarycolorectalcancerwithgenetictesting;10.Administrationofacomprehensionquestionnairetousers;11.Rateofindicationofpsychologicalassessmentofusersinthe program.c:Levelofcomplianceofoutcomeindicators.12.Adherencetosurveillancepreventivestrategiesinpatientswithcolorectaladenomas;13.Globaladherencetoscreeningandsurveillancepreventivestrategiesin usersathighriskofcolorectalcancer;14.Effectivenessoftheprogram(diagnosisofearlystageCRC);15.Adherencetoscreeningpreventivestrategiesinusersathighriskofcolorectalcancer;16.Administrationofa satisfactionquestionnairetousers;17.Administrationofaquestionnairetouserstomeasuretheimpactoftheprogramontheirphysicalandemotionalwell-being. INTL.J.OFTECHNOLOGYASSESSMENTINHEALTHCARE29:2,2013 170 Qualityindicatorsforcolorectalcancer Table2. DemographicandClinicalFactorsRelatedtoGlobalAdherencetoScreening presenteda14.4times(95percentCI,6.3–32.9)greaterproba- andPreventionStrategiesinUsersintheHRC-CRC,2006–2010:LogisticRegression bilityofcomplyingwithscheduledfollow-upexaminationsthan AnalysisofAdherencetoColonoscopies(n=613)a thoserelativeswithahigh-riskprofileforCRC.Usersreferred by other hospitals were 2 times more likely to adhere to the Variable OR(CI95%)raw OR(CI95%)badjusted program than those who came to the HRC-CRC on their own initiative,althoughdifferenceswerenotstatisticallysignificant. Finally, users who had undergone surveillance colonoscopies Gender were7.4(95percentCI,4.6–11.7)morelikelytoadheretothe Women 1c 1c programthanthosewhohadhadscreeningcolonoscopies. Men 1.4(1.0–2.0) 1.3(0.9–1.9) Age <45yearsold 1c 1c DISCUSSION 46–58yearsold 1.5(0.9–2.4) 1.5(0.9–2.4) To the best of our knowledge, this study is the first to evaluate >59yearsold 2.0(1.3–3.2) 2.0(1.3–3.1) thequalityofcareandtheareasofimprovementofaneworga- Personalriskstatus nizationalmodelforthepreventionofCRCinanincreased-risk Healthyrelativeathighrisk 1c 1c population, taking into account the entire care process and a Advancedcolorectaladenoma 3.8(2.6–5.7) 3.6(2.4–5.3) multidisciplinaryperspective.Somepublicationshaveassessed Colorectalcancer 7.9(3.9–15.8) 7.0(3.5–14.1) thequalityofcareofCRCpreventionprograms;however,most Polyposissyndrome 14.6(6.5–33.3) 14.4(6.3–32.9) ofthesestudieswereconductedinmedium-riskpopulationsand Endoscopicpreventionstrategy focused only on one or two aspects of the healthcare process. Screening 1c 1c For example, one study evaluated the quality of colonoscopies Surveillance 7.7(4.9–12.1) 7.4(4.7–11.7) ineightendoscopicservicesandincludedindicatorssuchasthe existenceofinformedconsent,medicationbeforecolonoscopy, Referraltothecoordinatingservice theavailabilityofcompletecolonoscopy,orcomplications(11). Patient’sowninitiative 1c 1c Anotherstudydevelopedfifteenindicatorsofqualityofcareto Otherhospitals 2.0(0.6–5.9) 2.0(0.7–6.3) assess colon surgery in patients with CRC (e.g., the appro- Intra-hospitalunits 1.7(0.9–3.3) 1.4(0.7–2.7) priateness of adjuvant therapy and postoperative surveillance Primarycare 0.5(0.3–0.9) 0.4(0.2–0.8) strategies)butonlyassessedtwospecificaspectsoftheorgani- aAdherence has been computed as the date differences between baseline and zational model of the HRC-CRC (colonoscopies and surgery) follow-upcolonoscopies;HRC-CC:High-riskclinicforcolorectalcancer.N=613 (12). Finally, some studies that included patient-centered indi- correspond to patients/users with two colonoscopies (baseline and follow-up). cators such as satisfaction with prevention strategies and ad- Nonadherence means that the patient had a baseline colonoscopy but did not herencetoscreeningcolonoscopiesof usersandtheirrelatives come for the scheduled follow-up colonoscopy. Users and patients who did not werealsocarriedoutinmedium-riskpopulations(usersaged50 haveasecondcolonoscopybecauseitdidnotapplyandthosewhodidnothavea andolderwithoutindividualorfamilyincreasedrisk)(13;14). baselinecolonoscopywereexcludedfromtheanalysis. Regardingtheprogram’spatientsafety,therateofcompli- bORadjustedbyageandgender. cations during colonoscopies was relatively low (0.6 percent) cReferencecategory. butgreaterthanthepublishedstandardsinmedium-riskpopula- HRC-CC,high-riskclinicforcolorectalcancer;OR,oddsratio. tions(0.1to0.3percent)(15;16).Nevertheless,greater-riskand medium-riskpopulationsarenotstrictlycomparableintermsof clinicalcharacteristicsandtypeofcomplications.Itispossible (2/2), 50 percent of the indicators that measured continuity of thatinhigh-riskpopulations,theincidenceofcomplicationsis healthcareachievedthestandard(2/4),28.6percentoftheindi- slightly greater due to the need for therapeutic maneuvers that catorsthatmeasuredpatient-centeredcareachievedthestandard are associated with increased risk of complications. It should (2/7), and 100 percent of the indicators that measured safety bementionedthatanincreasedwaitingtimeforgenetictesting reached the standard (1/1). Two indicators measuring continu- results in patients with a probable hereditary syndrome may ityofhealthcaredidnothaveapreviousreferencestandard. have an impact on their psychological well-being. This impact wasmentionedinaqualitativestudyonusersoftheHRC-CRC AdherencetotheScreeningandSurveillancePreventionStrategiesandRelated carriedoutinapreviousphaseoftheprojectforthedefinitionof Factors indicatorsaswellasinotherpublishedstudiesonperceivedout- Usersaged59andolderhadalmostatwotimesgreaterproba- come measures in genetic counseling and testing (8;17;18). In bility(95percentconfidenceinterval[CI],1.3–3.1)ofadhering future studies, complications from all the prevention interven- to screening and surveillance strategies than the younger age tions of a given program should be described, especially those group(<45years)(Table2).Userswithapolyposissyndrome thatmaybemoredifficulttomeasuresuchasthepsychological 171 INTL.J.OFTECHNOLOGYASSESSMENTINHEALTHCARE29:2,2013 Serra-Suttonetal. or physical discomfort caused by the program (colonoscopies, LimitationsoftheStudy geneticandmoleculartesting,preventivesurgery,etc.). Althoughtheassessmentofthequalityofcarebasedontheuse Regardingadherencetoscreeningandsurveillancepreven- ofindicatorsappearstoberelativelyeasytoperform,ithasre- tionstrategies,thequalitystandardwasmetinthesurveillance quiredacomplexreviewofdataquality.Theretrospectivenature strategy(patientswithhigh-riskcolorectaladenomas),butnotin ofstudyandtheuseofcomputerizedclinicalrecordsasthemain thescreeningstrategy.Thisloweradherenceinhealthyrelatives sourceofinformationhavehamperedtheprocessingofdatafor could be due possibly to a lower user perception of CRC risk analysis and the calculation of some indicators. This database than users with a diagnosis of polyposis syndrome, advanced was not developed for research purposes, but for the clinical colorectaladenomaorCRC.Otherpublishedstudiesshowsim- managementofusers.However,itwaspossibleforthefirsttime ilar results regarding factors, such as gender, age, and risk of toassessdataqualityandcompletenessfrominformation-based CRC,explainingdifferencesintheadherencetoscreeningand clinicalrecords.Finally,itshouldbementionedthatthehealth surveillancepreventionstrategies6;7;14;19;20).Thelowerad- ofuserschangesovertime,complicatingthedefinitionoftheir herence in healthy relatives with increased risk of CRC might risk profile for statistical analysis. We used the most definitive alsobeduetomultiplefactorssuchasindividualpsychosocial diagnosisatthetimeofanalysis,butuserscouldhavegonefrom characteristics, relationship with the doctor, family and social a “healthy profile” to a “polyposis syndrome” in a short time, environment,andlowerperceivedrisk(21–23). a fact that may have affected the accuracy of the association More and more often, current medical actions are aimed betweenadherenceandCRCriskprofiles. at prevention, as part of community programs for secondary preventionbutalsoaspartofmanyclinicalactivities,beingthe balancebetweenthebenefitsandrisksoftheseactivitiesinmany CONCLUSION casesuncertain(24).Inrecentpublications,severalauthorshave Severalindicatorshavebeenimplementedtoassessthequality criticizedtheheavyrelianceonhealthpreventionactivities(25– of care in the HRC-CRC. They have demonstrated their feasi- 27).Thepresentstudyfailedtodemonstratestrictlythebenefits bilityandconstructvaliditytoidentifyareasofimprovementof ofthepreventionprogramintermsofhealthgainsforthepopu- thisnewmodel,suchasinformationsystems,continuityofcare, lation,forinstancetheimpactoftheneworganizationalmodel andcommunicationamongprofessionals.Thisisoneofthefirst (the HRC-CRC) toreducethe incidenceof CRC or itsmortal- initiatives to have externally evaluated a CRC prevention pro- ity rate. In relation to the overall effectiveness of the program, graminahigh-riskpopulationinCatalonia.Thefactthatthere a lower percentage than expected of patients with early-stage arenopublishedstandardsforeachoftheindicatorsmakesthe CRC (0-I) were attended in the HRC-CC. Longer follow-ups study an innovative assessment tool. However, further assess- shouldbeperformedtoanalyzethecapabilityoftheprogramto ment or implementation of the indicators in other centers and detectearly-stageCRCpatients.Assaidbefore,atpresent,users intheHRC-CRCisstillrequiredtoimprovetheinterpretability are mainly referred to the HRC-CRC from other hospital ser- oftheresults. vices,whichmayexplaintheincreasedseverityofthepatients’ disease. Indicators that were not implemented in the present project,suchascolorectalcancerthatisdiagnosedbetweentwo SUPPLEMENTARYMATERIAL colonoscopies(intervalCRC)ortheoveralleffectivenessofthe SupplementaryMaterial: programtodetectCRC,aswellotherpatient-perceivedindica- www.journals.cambridge.org/thc2013089 tors such as the previously mention impact of the program on the psychological and physical well-being of users, need to be measuredinfuturestudies. CONTACTINFORMATION Becausetheindicatorshavebeenappliedinasinglecenter Victoria Serra Sutton, Sociologist, PhD, (vserra@aatrm. and at baseline, this could lead to limitations in the interpre- catsalut.cat), Catalan Agency for Health Research and Quality tation of compliance with the quality standards. The fact that andCIBEREpidemiolog´ıaySaludPu´blica,Barcelona,Spain there are no published standards for each of the indicators, or Carmela Barrantes Serrano, MD, University Hospital Vall the absence of consensus on some of them, hampers the in- Hebroń,PreventiveMedicineService,Barcelona,Spain terpretationofresults.FurtherassessmentoftheHRC-CRCor Mireia Espallargues Carreras, MD, PhD, Catalan Agency the implementation of indicators in other prevention programs for Health Research and Quality and CIBER Epidemiolog´ıa y to assess the quality of care and to confirm the robustness and SaludPu´blica,Barcelona,Spain validity of the indicators is therefore required (28;29). 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