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P.Re.Val.E.: outcome research program for the evaluation of health care quality in Lazio, Italy. PDF

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Fuscoetal.BMCHealthServicesResearch2012,12:25 http://www.biomedcentral.com/1472-6963/12/25 RESEARCH ARTICLE Open Access P.Re.Val.E.: outcome research program for the evaluation of health care quality in Lazio, Italy Danilo Fusco1*, Anna P Barone1, Chiara Sorge1, Mariangela D’Ovidio1, Massimo Stafoggia1, Adele Lallo1, Marina Davoli1 and Carlo A Perucci2 Abstract Background: P.Re.Val.E. is the most comprehensive comparative evaluation program of healthcare outcomes in Lazio, an Italian region, and the first Italian study to make health provider performance data available to the public. The aim of this study is to describe the P.Re.Val.E. and the impact of releasing performance data to the public. Methods: P.Re.Val.E. included 54 outcome/process indicators encompassing many different clinical areas. Crude and adjusted rates were estimated for the 2006-2009 period. Multivariate regression models and direct standardization procedures were used to control for potential confounding due to individual characteristics. Variable life-adjusted display charts were developed, and 2008-2009 results were compared with those from 2006- 2007. Results: Results of 54 outcome indicators were published online at http://www.epidemiologia.lazio.it/prevale10/ index.php. Public disclosure of the indicators’ results caused mixed reactions but finally promoted discussion and refinement of some indicators. Based on the P.Re.Val.E. experience, the Italian National Agency for Regional Health Services has launched a National Outcome Program aimed at systematically comparing outcomes in hospitals and local health units in Italy. Conclusions: P.Re.Val.E. highlighted aspects of patient care that merit further investigation and monitoring to improve healthcare services and equity. Background The Mattoni-Outcome Project, funded by the Italian Overthelasttwodecades,therehasbeenincreasinginter- Ministry of Health[13], and the subsequent Progr.Es.Si. est in the development and implementation of outcome Project, have beenthe mainnational experiences in this and process indicators. Such indicators encourage field.TheMattoni-OutcomeProjectmethodologieswere accountabilityandimprovements inthequalityofhealth the starting point for the Regional Outcome Evaluation careservices;theyalsoguideaccreditationandhealthcare Program,calledP.Re.Val.E.[14,15],whichwasconducted planninginterventions[1-6].Publicandprivateorganiza- intheLazioregionofItaly(5,493,308residents[16]).P. tions,aswellasresearchprojects,haveuseddifferentindi- Re.Val.E.isthemostcomprehensivecomparativeevalua- cators for comparative evaluation of the performance of tionofregionalhealthcareoutcomesandtheonlyItalian healthcareprovidersandprofessionals.Somehavereleased studytopubliclydiscloseperformancedata. theirresultstothepublicintheformofweb-basedreports The objectives of P.Re.Val.E. were to define and evalu- thatcomparehospitalquality[7-13]. ate outcome/process indicators in order to: In Italy, national and regional outcome research pro- grams have been conducted, but there has been no sys- (cid:129) compare the outcomes of health care provided by tematic comparison of outcomes at the national level. different hospitals or in different geographical areas for purposes such as accreditation, remuneration, *Correspondence:[email protected] and enhancing citizen empowerment; 1DepartmentofEpidemiology,RegionalHealthService-LazioRegion,via SantaCostanza53,Rome,00198,Italy Fulllistofauthorinformationisavailableattheendofthearticle ©2012Fuscoetal;licenseeBioMedCentralLtd.ThisisanOpenAccessarticledistributedunderthetermsoftheCreativeCommons AttributionLicense(http://creativecommons.org/licenses/by/2.0),whichpermitsunrestricteduse,distribution,andreproductionin anymedium,providedtheoriginalworkisproperlycited. Fuscoetal.BMCHealthServicesResearch2012,12:25 Page2of10 http://www.biomedcentral.com/1472-6963/12/25 (cid:129) compare population subgroups (e.g. socioeconomic TheHISdatabasewastheprimarysourceforcaseselec- subgroups), especially for evaluating and promoting tion and outcomes/comorbidities data. We also used equitable service provision; information from the EIS database to better identify (cid:129) identify the minimum volume of activity associated comorbiditiesandtoestimatethetimetodeathortimeto with the best treatment outcomes; surgery after arrival at the hospital (i.e. admission to the (cid:129) promote internal and external auditing; Emergency Department or to a hospital ward). Deaths (cid:129) identify critical areas in which to implement pro- duringthestudyperiodwereidentifiedusingtheHIS,the grams that improve health care quality; EIS,andthe MIS.TheRADRdatabasewasused to iden- (cid:129) monitor trends in health care quality over time. tifyadmissiontoarehabilitationcenterfollowinghospital admissionforstroke.Finally,we usedtheHDISdatabase In order to highlightdifferences in the performance of for more accurate identification of new births, primary localcommissioningauthorities,P.Re.Val.Eevaluatedout- cesarean deliveries, and risk factors for cesarean section comesaccordingtopatientresidence.Importantly,direct whicharenotincludedintheHIS. standardizationmethods[17-20]ratherthanindirectstan- HIS records were linked with EIS, MIS, RADR, and dardization methods [5,7,10,20] were used for the com- HDIS records using deterministic record-linkage. To parativeevaluationofoutcomes.Theaimofthisreportis ensuremaximumcoverageofthepopulationwhileavoid- todescribetheP.Re.Val.E.program,includinginformation ing double counting, the linkage method uses a unique sources, statistical methodologies, results for 2006-2009 patient identifier deriving from information on persons’ (published online at http://www.epidemiologia.lazio.it/ names, date and place of birth and gender, according to vislazio/vis_index.php,andthe updated Italianversionat Italianprivacylegislation. http://www.epidemiologia.lazio.it/prevale10/index.php), and the impact of releasing performance data to the Study population public. P.Re.Val.E.analyzedhospitaldischargesintheLazioregion inthe2006-2009period[14].Mostdatawereexpressedas Methods ratios in which the numerator represents the number of Study design and data sources treatments/interventions provided or the number of Wedefined54performanceindicatorsindifferentclinical patientswitha givenoutcome (i.e.,short-termmortality, areasthatincludedtreatmentforcardiac,cerebrovascular, hospitalization for specific conditions, etc.) and the orthopedic, obstetric,respiratory,anddigestivedisorders denominator represents the group of patients at risk. In [14]. Some were health outcome indicators, such as 30- othercases,theindicatorsweredefinedassurvival/waiting daymortalityafteranepisodeofmyocardialinfarctionor time(e.g.,thewaitforsurgeryafterhipfracture). 30-day complications aftercholecystectomy;otherswere The analyses were performed, two years over two processindicatorsforwhichanassociationwithimproved years, by area of residence regardless of the hospital at health outcomes has been already proven, such as inter- which the patient was treated and by hospital. ventionwithin48hoursofhospitaladmissionforhipfrac- ture in the elderly. Finally, hospitalization rates for Definition and attribution of outcome pathologies generally treated out of the hospital, such as Theoutcomemeasureswereasfollows:30-daymortality, diabetes,asthma,andinfluenza,wereconsideredanindi- short-term re-hospitalization, hospitalizationfor specific cationoffailureinprimarycare[21]. conditions,surgicalprocedures,short-termcomplications Most indicators were selected based on their previous ofspecificinterventions,andwaitingtimes.Theoutcomes use in international and national studies [7-19,21-24], understudywereattributedtothefirstemergencydepart- whileotherindicatorsweredevelopedinordertodescribe ment at which the patient was treated(firstaccess)orto particular components of care or clinical pathways. A thefirstadmissionhospitalandtotheareaofresidence. rationaleandadetailedoperativeprotocolwereelaborated for each indicator according to a standard outline [14]. Coexisting medical conditions The indicators were defined using information collected Chroniccomorbiditiesand/orseveritycharacteristicsthat from regional health information systems covering the were potentially associated with the outcomes under wholeLaziopopulation:theHospitalInformationSystem study were chosen using information in the literature (HIS),theEmergencyInformationSystem(EIS),theMor- [7-9,17,18,21-23,25-30] and in the Mattoni-Outcome tality Information System (MIS), the Report Admission- project[13].Thepotentialriskfactorswereidentifiedon Discharge for Rehabilitation (RADR), and the Hospital the basis of ICD-9-CM codes registered either during DeliveriesInformationSystem(HDIS).Fordetailedinfor- hospitalizationfortheconditionunderstudy(indexhos- mation about each,please seehttp://www.epidemiologia. pitalization)orinprevioushospitaloremergencydepart- lazio.it/vislazio_en/fonti.php. ment admissions during the previous two years. Acute Fuscoetal.BMCHealthServicesResearch2012,12:25 Page3of10 http://www.biomedcentral.com/1472-6963/12/25 eventsoccurringduringtheindexhospitalization,which usedtheclustersandwich("robust”)variance-covariance could be complications of care/treatments (i.e. on the estimators,relaxingtheusualrequirementthattheobser- causal pathway between exposure and outcome), were vationsareindependent.Accordingtothismethodology, notincluded. the observations are independent across groups but not necessarilywithingroups. Statistical analysis The adjusted RR estimated for each hospital/area of Statisticalanalyseswere performedbyfirstadmissionor residence, the adjusted risk or median waiting time, and access hospital as well as by area of residence. Since the corresponding p-value were reported on-line in tab- patient characteristics, such as age, sex, severity of dis- ular and graphical forms. ease, and/or chronic comorbidities, could be heteroge- For each indicator, trend analyses and comparisons of neously distributed across the hospitals/areas of the 2008-2009 data versus the 2006-2007 data were residence, risk-adjustment methods were applied [31]. developed by hospital and area of residence. The riskadjustmentprocedure involved construction of Variable Life-Adjusted Display (VLAD) charts [34,35] a severity measure (“a priori” risk) that was specific for were constructed to identify the principal increases/ the study population and the use of this measure to decreases and trend reversals in the cumulative sums of obtain “adjusted” outcome measures for comparison the differences between the number of events observed betweenhospitals/areas.Theseveritymeasurewascalcu- (deaths, rehospitalizations, reoperations, complications, lated by analyzing the multivariate relationship between etc.) and the number expected based on the predictive possibleoutcomepredictorsandtheoutcomeconsidered model. Two tests of statistical significance were per- byapplicationofmultivariateregressionmodels(predic- formed, the first to determine whether during the study tive models) including: 1) a prioririsk factors (age, sex, period, the number of events observed in one month and/orseverity of the conditionbeinginvestigated); and (from the second day of the previous month to the first 2) factors selected by a bootstrap stepwise procedure. day of the following month) was significantly different Stepwise analysis was performed with 500 replicated from the number of expected events and the second to samples of the original data and significance thresholds determine whether the number of observed events of0.10and0.05forentryandremoval,respectively. between2trend-reversalpointswassignificantlydifferent Only risk factors (pre-existing chronic conditions, etc.) from the number of expected events. Both significance selected in at least 50% of the runs were included in the tests were performed using the ratio of observed to final models expectedeventsassumingaPoissondistribution. We used logistic regression models for dichotomous Finally, since higher activity volumes of the hospitals outcome variables and survival models for outcomes areoftenassociatedwithbetteroutcomes,wealsoinves- expressedintermsofsurvivaltimes. Inordertoestimate tigatedthoserelationships(displayedasscatterplots). adjusted group-specific (hospital/area of residence) log The level of statistical significance was set at 5% (p < oddsofoutcome,logisticregressionmodelswithnointer- 0.05), and all analyses were performed using SAS Ver- cept and centred covariates were applied for each out- sion 8.2 [36]. come. Adjusted risks were obtained for each group by back-transformingparameterestimateswiththefollowing Preliminary disclosure of performance data to clinicians formulas: and providers Before public release of data, we shared the P.Re.Val.E Adjrisk=[exp(estimate)/(1+exp(estimate))]*k methods and results with different groups of clinicians andproviders,topromotediscussionandencouragecon- where k is a correction coefficient introduced to take tributionsandcriticalassessments. into account the nonlinear nature of the logistic model. K is calculated as follows: Results actual number of events Wecalculated54indicators,9ofwhich wereprevention k= (cid:2)m qualityindicators,thatcoveredalmost40%ofallhospital p ∗n j j admissions in the Lazio Region during the 2008-2009 j=1 period. The results obtained for all indicators, available where p are the adjusted risks, n is the group size, online at http://www.epidemiologia.lazio.it/prevale10/ j j and m is the number of groups. index.php,showedagreatheterogeneityofthehealthcare Thisapproachallowed comparisonoftheoutcomefor qualityintheLazioregion. agivenfacilityorareaofresidencewiththatofthewhole Public disclosure of the indicators’ results caused study population and with each of the other facilities/ mixed reactions but finally promoted discussion and areas[18,32,33].Inordertoassessforclustereffects,we refinement of some indicators, e.g., for 30-day mortality Fuscoetal.BMCHealthServicesResearch2012,12:25 Page4of10 http://www.biomedcentral.com/1472-6963/12/25 after aortic aneurysm. These meetings led to new esti- Theadjustedmortalityratesrangedfrom6.7%to19.2%in mates for some indicators and stimulated audit activities different hospitals, and from8.8% to 13.7% for different among clinicians and healthcare organizations. areasofresidence(Tables2and3).Intheprevious2-year In 2008, Agency for Public Health of Lazio designed a periodtherewere17436AMIepisodes,themeanmortality clinical pathway for elderly patients with hip fracture. ratewas12.2%,withhighvariabilityamongthedifferent The clinical pathway was tested in five selected hospitals facilitiesandareas.Ingeneral,theadjustedmortalityrates before the implementation in all Lazio hospitals. showedasmalldecreaseovertimeformostfacilitiesand In 2009, a regional health service regulation went into areas(datanotshown).AlthoughtheVLADchartswere effect that required Lazio hospitals to adopt the clinical developedforeachfacilityandarea,theresultsfromtwo pathway for elderly patients with hip fracture and that largehospitalsthatshowedverydifferenttimetrendsfor introducedacompensationsystemforhospitalsbasedon 30-daymortalityafterAMIadmissionwerereportedonly. qualityofhealthcare(asinapay-for-performancemodel). In2008-2009,PresidioOspedalieroNord,Latina,showeda The DRG reimbursement rate for Lazio providers was greaternumberofobserveddeathsafterAMIadmission linkedtohospitalperformance.Infact,from2009on,the than expected, with a little decrease in November 2009 fullDRGratehasonlybeenpaidforpatientswhounder- (Figure1),whereasSanFilippoNeri,Rome,generallyhad went surgicaltreatmentwithin48hours after admission, fewerobservedeventsthanexpectedones(Figure2). while rates for interventions performed after 48 hours werereducedproportionallybasedonthetimetosurgery. Discussion and Conclusions BasedontheP.Re.Val.E.experience,theItalianNational Comparativeevaluationofhospitalperformanceisause- Agency for Regional Health Services has launched a ful tool for improving healthcare quality [1,4]. The U.S. NationalOutcomeProgramaimedatsystematicallycom- experiencehasshownthatpublicdisclosureofcompara- paring outcomes in hospitals and local health units in tiveevaluationresultsshouldbemanagedasonecompo- Italy. nent of an integrated quality improvement strategy, and As anexample, results pertaining the 30-day mortality thatthepublicreleaseofperformancedataismosteffec- rateafterhospitaladmissionforacute myocardialinfarc- tiveattheleveloftheproviderorganization[3,4,37].Reg- tion(AMI)inLazioregionwereshown[fortheoperative ular feedback seems to increase the accountability of protocol see: additional File 1, Appendix: operative providers,whicharesensitivetopublicimageandpoten- protocol]. tiallegalrisks;itcanalsospurqualityimprovementactiv- Therewere16,682AMIepisodesin2008-2009witha ities in health care organizations, especially when meanmortalityrateof11.1%(men:8.9%;women:15.2%). underperformingareasareidentified[38].However,pro- Theprobabilityofdeathwas2timeshigherwhenchronic viders that are identified as poor performers are more diseases(liver,pancreas,intestine)intheindexadmission, likely to question the validity of the data, particularly cancerandothercardiacoperationswerepresent(Table1). whentheresultsarefirstreleased[39]. Table 1Acute myocardial infarction: mortality within 30 daysofhospital admission, predictive model RiskFactors N CrudeOR AdjustedOR p Age(years) - 1.08 1.08 0.000 Gender(FemalesvsMales) 5767 1.84 1.05 0.419 Cancer 810 2.52 2.05 0.000 Hypertention 3072 1.52 0.85 0.024 Previousmyocardialinfarction 2481 0.96 0.73 0.000 Cardiomyopathy(indexadmission) 259 0.82 0.63 0.040 Cardiomyopathy 218 1.88 1.14 0.505 Heartfailure 1117 2.77 1.62 0.000 Otherheartconditions(indexadmission) 367 1.06 0.60 0.006 Otherheartconditions 228 1.83 1.08 0.688 Cerebrovasculardisease 1122 2.43 1.47 0.000 Vasculardisease 679 2.23 1.57 0.000 Chronicrenaldisease 876 2.82 1.66 0.000 Otherchronicdisease(liver,pancreas,intestine)(indexadmission) 105 2.52 2.33 0.001 Otherchronicdisease(liver,pancreas,intestine) 209 1.98 1.35 0.135 Previouscoronaryangioplasty 1417 0.57 0.65 0.000 Othercardiacinterventions 127 1.69 2.06 0.006 Fuscoetal.BMCHealthServicesResearch2012,12:25 Page5of10 http://www.biomedcentral.com/1472-6963/12/25 Table 2Acute myocardial infarction: mortality within 30 daysofhospital admission, by health carefacility Hospital Location N Cruderate×100 Adjustedrate×100 AdjustedRR p OSP.S.CAMILLODELELLIS RIETI 509 12.57 12.23 1.10 0.461 OSP.S.SPIRITO ROME 574 10.28 8.43 0.76 0.049 OSP.ANZIO-NETTUNO ANZIO 351 9.69 9.11 0.82 0.269 OSP.ALBANO-GENZANO ALBANO 361 13.02 12.75 1.15 0.366 OSP.S.PAOLO CIVITAVECCHIA 298 14.77 13.86 1.25 0.162 OSP.PARODIDELFINO COLLEFERRO 320 8.75 8.23 0.74 0.129 OSP.S.SEBASTIANO FRASCATI 250 12.80 11.99 1.08 0.675 OSP.S.GIOVANNIEVANG TIVOLI 200 19.50 19.17 1.73 0.001 OSP.GRASSI ROME 648 9.72 9.17 0.83 0.152 OSP.S.EUGENIO ROME 485 13.81 12.25 1.10 0.454 OSP.S.PIETROF.B.F. ROME 232 12.93 14.02 1.26 0.216 OSP.VANNINI ROME 706 10.62 10.89 0.98 0.874 CCS.ANNA POMEZIA 179 12.29 17.45 1.57 0.034 CCNUOVAITOR ROME 258 14.73 10.60 0.96 0.792 CCCITTA’ROMA ROME 203 8.37 6.72 0.61 0.046 CCAURELIAHOSPITAL ROME 396 10.35 10.59 0.95 0.775 PRES.OSP.NORD LATINA 690 11.30 13.49 1.22 0.096 PRES.OSP.SUD FORMIA 500 11.80 13.16 1.19 0.204 CCCITTA’DIAPRILIA APRILIA 245 13.47 13.48 1.22 0.286 OSP.UMBERTOI FROSINONE 556 9.17 10.07 0.91 0.502 OSP.CIVILE ANAGNI 152 9.87 10.98 0.99 0.968 OSP.S.S.TRINITA’ SORA 220 10.91 11.44 1.03 0.885 OSP.G.DEBOSIS CASSINO 222 9.46 8.85 0.80 0.323 OSP.S.PERTINI ROME 763 11.40 11.99 1.08 0.491 OSP.BELCOLLE VITERBO 602 10.96 12.40 1.12 0.386 A.O.S.CAMILLO-FORLANINI ROME 1021 12.83 13.00 1.17 0.088 A.O.S.GIOVANNI ROME 679 7.81 7.52 0.68 0.007 A.O.S.FILIPPONERI ROME 770 10.91 11.58 1.04 0.708 POLICLINICOA.GEMELLI ROME 695 8.06 7.73 0.70 0.011 POLICLINICOUMBERTOI ROME 557 10.23 11.88 1.07 0.619 A.O.S.ANDREA ROME 615 4.88 6.16 0.55 0.001 A.O.POL.TORVERGATA ROME 505 5.94 9.67 0.87 0.451 RR:RelativeRisk In Italy, initiatives aimed at assessing the outcomes of factorsor their effects do not vary betweenthe hospitals hospital care have been undertaken at the national and beingcompared. regionallevelsonlyinthelastdecade[13,17,40,41].Based After receiving comparative reports based on standar- ontheseexperiences,wedevelopedtheRegionalOutcome dized performance measures, hospitals that began as Evaluation Program, called P.Re.Val.E. [14]. The high low-level performers tended to improve faster than numbersofpatientsinvestigated,theaccuracyintheselec- those that started at higher levels of performance [42]. tion of the cohorts and the study outcomes, the consoli- Sincestudieshaveshownlittlecorrelationbetweenmea- dated statistical strategy, and the replication of similar sured quality of care and Standardized Mortality Ratios findingsfordifferentclinicalconditionsareimportantele- (SMRs)[43,44],weuseddifferentoutcomeand/orprocess ments of internal and external validity. For 2006-2009, measuresforeachstudiedconditiontobetteridentifythe results were obtained using direct risk adjustment for hospitals/geographicareasthatneededhealthcarequality comparative evaluation of outcomes for hospitals and improvement. This study used data from several health areas of residence. Hospital league tables obtained by careinformationsystems,andmostoftheindicatorswere indirectstandardizationproceduresshouldnotbeusedfor basedontheconceptoffirsthospitalaccess,correspond- hospital-to-hospitalcomparisons[20].Thistechniquecan ingtopatientadmissiontoanacuteinpatientfacilityorto lead to biased conclusions unless the distribution of risk emergency department access. The indicators for which Fuscoetal.BMCHealthServicesResearch2012,12:25 Page6of10 http://www.biomedcentral.com/1472-6963/12/25 Table 3Acute myocardial infarction: mortality within 30 daysofhospital admission, by area ofresidence Area N Cruderate×100 Adjustedrate×100 AdjustedRR p RomeDistrictI 385 10.39 9.31 0.84 0.297 RomeDistrictII 312 10.90 8.80 0.79 0.202 RomeDistrictIII 129 15.50 12.39 1.12 0.641 RomeDistrictIV 567 9.70 9.04 0.82 0.152 RomeDistrictV 709 10.86 11.13 1.00 0.982 RomeDistrictVI 515 11.65 11.06 1.00 0.981 RomeDistrictVII 298 9.40 9.86 0.89 0.546 RomeDistrictVIII 565 9.03 10.96 0.99 0.932 RomeDistrictIX 351 12.25 10.06 0.91 0.548 RomeDistrictX 454 9.69 10.44 0.94 0.696 RomeDistrictXI 415 14.70 12.49 1.13 0.387 RomeDistrictXII 427 11.94 11.26 1.01 0.922 RomeDistrictXIII 700 11.43 10.92 0.98 0.891 Fiumicino 221 9.50 9.90 0.89 0.620 RomeDistrictXV 445 11.46 10.31 0.93 0.623 RomeDistrictXVI 424 12.97 11.52 1.04 0.794 RomeDistrictXVII 268 13.43 10.19 0.92 0.636 RomeDistrictXVIII 393 12.72 11.46 1.03 0.827 RomeDistrictXIX 594 11.62 10.05 0.91 0.444 RomeDistrictXX 414 11.84 12.84 1.16 0.329 ASLRM/F 894 10.07 10.04 0.90 0.368 ASLRM/G 1278 10.95 11.78 1.06 0.500 ASLRM/H 1693 10.16 10.92 0.98 0.846 Viterbo 182 9.34 8.77 0.79 0.347 ViterboProvince 741 12.42 13.08 1.18 0.132 Rieti 181 9.39 9.37 0.84 0.504 RietiProvince 329 13.37 13.16 1.19 0.281 Latina 307 11.73 12.45 1.12 0.511 LatinaProvince 1223 11.37 12.73 1.15 0.124 Frosinone 180 11.67 13.71 1.24 0.345 FrosinoneProvince 1088 9.93 10.62 0.96 0.662 RR:RelativeRisk timetodeathortosurgerywascalculatedfromfirsthospi- The P.Re.Val.E. results for 2008-2009 [14] provided an tal access provide a measure of the appropriateness and overview of the hospital care heterogeneity in the Lazio efficacy of the health care process that begins when a region. The results do not constitute a “league table” of patientarrivestoagivenfacility.UseoftheMIS andEIS performance, but instead reveal numerous instances of databases,inaddition to theHIS database, allowedmore high-quality care as well as problem areas that merit accurateidentificationof30-daymortality. further analysis and internal and external auditing as To monitor the time trends of the different outcomes, part of an increasingly well-developed program of clini- we used VLAD charts, a type of quality control chart cal governance. that is a good tool for measuring the variability of an P.Re.Val.E. is an outcome research program conceived event adjusting for patient risk [34,35,45,46]. VLAD mainly as a tool for promoting discussion among health- charts provide an easy-to-understand and up-to-date care managers and professionals in the Lazio region. view that allows early detection of runs of good or bad Given the complexities of accurately comparing provider outcomes and thus can prompt timely intervention for outcomes, we published the methods used for develop- critical situations. The VLAD charts also highlight small ing the program in detail, using others’ suggestions for variations over time for observed events compared to the public reporting of comparative health outcome eva- expected events; this information is often obscured by luations [47] so that the face validity of the results could the corresponding synthetic indicator. be evaluated. We also used various tools to present the Fuscoetal.BMCHealthServicesResearch2012,12:25 Page7of10 http://www.biomedcentral.com/1472-6963/12/25 Figure1VLADchart.Acutemyocardialinfarction:mortalitywithin30daysofhospitaladmission.HospitalPresidioOspedalieroNord,Latina. results in order to make the results accessible; in parti- aimed at creating an incentive to improve results. In cular, we used bar graphs to clearly display adjusted fact, studies describing the effect of public reporting on estimates, as well as tables that included the number of consumers’ choices, effectiveness, patient safety and admissions, the crude and adjusted estimates, and the patient-centeredness have shown that the public release statistical significance of the results. of performance data mainly stimulates change at hospi- Public disclosure of the 2006-2009 results to clini- tal level [48]. There have been some negative reactions, cians, health care managers, and policy makers was but in most cases, the results have stimulated increased Figure2VLADchart.Acutemyocardialinfarction:mortalitywithin30daysofhospitaladmission.HospitalS.FilippoNeri,Rome. Fuscoetal.BMCHealthServicesResearch2012,12:25 Page8of10 http://www.biomedcentral.com/1472-6963/12/25 review among health care organizations and profes- the P.Re.Val.E. update for 3 conditions, namely AMI, sionals. Clinicians and program developers have met aortocoronarybypass,andhipfracture,sincesomeclini- several times to discuss the methodology as well as cal information (e.g., systolic blood pressure, ejection negative findings, such as poor performance or poor fraction,creatinine)havebeenrecentlyaddedtotheHIS coding accuracy. Physicians have made suggestions [60]. Moreover, in these 3 conditions, intrinsic illnesses about more accurate selection criteria for some indica- at the time of patients’ admissions can be distinguished tors. As a consequence of the extremely low proportion fromcomplicationssince “present on admission”(POA) of interventions for hip fracture in the elderly within 48 flags have been added to discharge diagnoses [61]. The hours in most facilities, the regional authority decided problem of under-recording is also partially solvable by that hospitals with performance results below a given using prior patient hospitalization records to identify standard would be penalized economically by a reduc- comorbidities independent of patient severity at the tion in fees corresponding to specific Diagnosis Related currentadmission[61] as wellas emergencydepartment Groups (DRGs) [49]. visitstocollectadditional informationaboutpatientrisk P.Re.Val.E. is a program in progress, and it will be factors. However, the coding accuracy may differ widely updatedandfurtherdevelopedbythedefinitionandcal- among the facilities [62], and this could lead to biased culationofadditionalindicators,e.g.,thoseaimedateval- comparisons. Even though the possibility of gaming of uating health care quality for oncology patients, and by thedatainresponsetothe performance evaluation can- the use of regional drug dispensing registries to more not be excluded, previous studies did not find evidence accurately identify patient comorbidities. The impact of ofgaming[63].Somestudieshavereportedthatchanges health care performance information disclosure to the in data accuracy may partially explain quality improve- general public should be evaluated. Evidence suggests ment[64].However,wedidnotfindrelevantchangesin thatthisinformationhasonlyalimitedimpactonconsu- recordingofco-morbiditiesinourstudypopulationover mer decision-making [39] since people have limited the years (data not shown). In agreement with previous access to data on health care providers [50]; however, reports,theprevalenceofcertainco-morbiditiesandrisk studiessuggestthatpeopleareinterestedincomparative factors was relatively low in our study population, indi- information[51,52]. cating underreporting of co-morbidities and detailed Theseanalyseshaveexplicitlimitations,especiallywith clinical information in the administrative database [65]. regardtothemarkedvariabilityinthecodingaccuracyof However, underreporting was non-differential in the currenthealthcareinformationsystems.Thisissueiscri- yearsincludedinouranalysis.Moreover,a previousIta- tical for ensuring accurate risk adjustment, and, corre- lian study [65] assessing clinical performance in cardiac spondingly, reliable comparative quality ratings [53]. In surgery demonstrated that the use of an administrative the past, administrative databases have too frequently database provided similar league tables as a more com- beenusedexclusivelyastoolstoclaimfinancialreimbur- plexspecializeddatabase. sement for services provided without concern for their Finally,sincehealthcareservicescanonlybeevaluated roles as epidemiologic sources and as essential instru- byempiricalmeasurements,inevitablytherewillbeerrors mentsforclinicalgovernance.Therearesomeimportant (systematicandrandom).Thisrepresentsaclearlimitation advantages to routinely collectingadministrative data:it ofouranalysisaswellasothersofthistype.Weagreewith is inexpensive to do this, and the data provide informa- Shahianetal.thathospitalmortalityestimatescouldvary, tionaboutlargepopulations,donotdependonvoluntary sometimes widely, based on the different case-selection participation by individual clinicians and providers, and criteriaandstatisticalmethods,leadingtodivergentinfer- can be used to predict risk of death with discrimination ences about relative hospital performance. Despite these comparable with that obtained from clinical databases concerns,somefindingscouldbeusefultopotentialusers [54].However,theuseofroutinelycollectedadministra- or to facilities [66]. P.Re.Val.E. openly declares the data tive data in comparative outcome evaluations has been sources and methods, allowing external review of biases criticizedforthefollowingreasons:thereisanabsenceof and distortions implicit to the evaluation process. The clinical information needed to adequately adjust for nextP.Re.Val.E.analysis,expectedinNovember2011,will patients’conditions[55,56];thereisaninabilitytodistin- include improvements in methods and procedures; of guish between a disease present at admission (a comor- course,we cannotsaythatotherbiases willnotbeintro- bidity, i.e. a true patient risk factor) and one that duced,simplythatthey willbedifferent.It isourconvic- occurred during the hospital stay (i.e. a complication) tion, however, that P.Re.Val.E. is an important operative [56,57] and some chronic comorbidities, such as hyper- toolthatshouldbeusedtopromoteclinicalandorganiza- tension and diabetes, are known to be currently under- tionalmonitoringofhealthcareproviders,tosupportpoli- reported at admission, mainly in more severely affected ticaldecision-making processes,andto stimulate asense patients[58,59].Thefirstproblemcouldbeovercomein of healthy, productive competition aimed at improving Fuscoetal.BMCHealthServicesResearch2012,12:25 Page9of10 http://www.biomedcentral.com/1472-6963/12/25 healthcareefficacyandequity.Wehopethatthisprogram InfarctionQualityIndicatorPanel.Indicatorsofqualityofcarefor will encourage a value often neglected within the Italian patientswithacutemyocardialinfarction.CMAJ2008,179(9):909-915. 10. HealthGrades.TheSeventhAnnualHealthGradesHospitalQualityand NHS:accountability. ClinicalExcellenceStudy. Lakewood,CO:HealthGrades2009[http://www. healthgrades.com/media/DMS/pdf/ HospitalQualityClinicalExcellenceStudy2009.pdf]. Additional material 11. EUPHORIC-EUropeanPublicHealthOutcomeResearchandIndicators Collectionproject.[http://www.euphoric-project.eu]. Additionalfile1:Appendix:operativeprotocol.30-DayMortalityRate 12. MattkeS,KelleyE,SchererP,HurstJ,LapetraMLG,theHCQIExpertGroup afterhospitaladmissionforAcuteMyocardialInfarction(AMI). Members:HealthCareQualityIndicatorsProjectInitialIndicatorsReport. OECDHealthWorkingPapers2006,22. 13. MinistryofHealth,Italy.Mattoni-outcomeproject.[http://www.mattoni. salute.gov.it/]. 14. LazioRegionalHealthService(RHS)OutcomeEvaluationProgram2006- Acknowledgements 2009.,http://www.epidemiologia.lazio.it/vislazio/vis_index.phpandhttp:// WewouldliketothankFedericaAsta,PaolaColais,MirkoDiMartino,and www.epidemiologia.lazio.it/prevale10/index.php. 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