Quality of Diabetes Care Predicts the Development of Cardiovascular Events: Results of the AMD-QUASAR Study.

0.85 MB·English

by  Rossi, Maria C.E.

Epidemiology/Health Services Research
O R I G I N A L A R T I C L E
Quality of Diabetes Care Predicts the
Development of Cardiovascular Events:
Results of the AMD-QUASAR Study
MARIA C.E. ROSSI, MSC, PHARM, CHEM1 FABIO PELLEGRINI, MSC, STAT1 prescribed in the presence of a specific
GIUSEPPE LUCISANO, MSC, STAT1 UMBERTO VALENTINI, MD6 indication).Outcomemeasuresarethere-
MARCO COMASCHI, MD2 GIACOMO VESPASIANI, MD7 sultsof a patient health status as a conse-
CARLO COSCELLI, MD3 ANTONIO NICOLUCCI, MD1 quenceofthecaredelivered.Intermediate
DOMENICO CUCINOTTA, MD4 ON BEHALF OF THE AMD-QUASAR STUDY outcomes include laboratory measure-
PATRIZIA DI BLASI, MD5 GROUP*
GIOVANNI BADER, MD5 ments,physicalsigns,orsymptoms.
Although widely used by many or-
ganizations worldwide, it is unclear
OBJECTIVE—The QUASAR (Quality Assessment Score and Cardiovascular Outcomes in whether selected indicators, which usu-
ally include process and intermediate
ItalianDiabetesPatients)studyaimedtoassesswhetheraquality-of-caresummaryscorepre-
dictedthedevelopmentofcardiovascular(CV)eventsinpatientswithtype2diabetes. outcomemeasures,trulyreflectthequal-
ity of care delivered and its long-term
RESEARCHDESIGNANDMETHODS—In67diabetesclinics,dataonrandomlyse- consequences (10). Outcome measures
lectedpatientswereextractedfromelectronicmedicalrecords.Thescorewascalculatedusing have been criticized because they can be
process and outcome indicators based on monitoring, targets, and treatment of A1C, blood
affected byfactors other thanthequality
pressure,LDLcholesterol,andmicroalbuminuria.Thescorerangedfrom0to40.
ofcare,suchaspatientcharacteristicsand
RESULTS—Overall,5,181patientswereanalyzed;477(9.2%)patientsdevelopedaCVevent attitudes (11). However, process mea-
afteramedianfollow-upof28months.Theincidencerate(per1,000person-years)ofCVeventswas sures alone do not fully describe the
62.4inpatientswithascoreof,15,41.0inthosewithascorebetween20and25and36.7inthose wholeprocessofcare.Asanexample,reg-
withascoreof.25.Multilevelanalysis,adjustedforclusteringandcase-mix,showedthattheriskto ular testing of HbA levels does not en-
1c
developanewCVeventwas84%higherinpatientswithascoreof,15(incidencerateratio[IRR]= sure that the physician will adequately
1.84;95%confidenceinterval[CI]1.29–2.62)and17%higherinthosewithascorebetween15and treat persistently elevated values (12).
25(IRR=1.17;95%CI0.93–1.49)comparedwiththosewithascoreof.25.Meanqualityscore
Furthermore,positiveresultsintheshort
variedacrosscentersfrom16.567.5to29.166.3.Whenthescorewastestedasthedependent
runcouldfailtobesustainedinthelong
variable,itemergedthat18%ofthevarianceinthescorecouldbeattributedtosettingcharacteristics. run,eveninthepresenceofscientifically
CONCLUSIONS—Ourstudydocumentedacloserelationshipbetweenqualityofdiabetes validated indicators. In fact, although
careandlong-termoutcomes.Asimplescorecanbeusedtomonitorqualityofcareandcompare widely used, it is unclear to what extent
theperformanceofdifferentcenters/physicians. process and intermediate outcome mea-
suresareabletopredictlong-termeffects
DiabetesCare34:347–352,2011 on patients’ health. The Associazione
T Medici Diabetologi(AMD),anItalian di-
hegrowingburdenoftype2diabetes Qualitymeasuresincludeprocessand abetes scientific society, developed qual-
mellitusanditscardiovascularcom- intermediateoutcomeindicators,selected ity indicators to be used for the routine
plications(1–2)hasforcedAmerican undertheassumptionthattheyarelinked monitoringofdiabetescare(9,13).Inpar-
and European organizations to work for todownstreamhealthoutcomes.Process allel,AMDlaunchedtheQUASAR(Qual-
thedevelopment,specification,andfield- measures denote what is actually done ityAssessmentScoreandCardiovascular
testingofmeasuresforqualityofdiabetes tothepatient(i.e.,whetherA1C[HbA ] Outcomes in Italian Diabetes Patients)
1c
care(3–9). has been measured or an ACE inhibitor studytoevaluatewhethertheseindicators
wereabletopredicttheincidenceoffinal
outcomes. In particular, we assessed
c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c whetheraquality-of-caresummaryscore
Fromthe1DepartmentofClinicalPharmacologyandEpidemiology,ConsorzioMarioNegriSud,SantaMaria estimated at baseline from the combina-
Imbaro,Chieti,Italy;the2EmergencyDepartment,UniversityHospitalSanMartino,Genova,Italy;the tionofthemainprocessandintermediate
3DivisionofInternalMedicine,HospitalofParma,Parma,Italy;the4DepartmentofInternalMedicine, outcome indicators predicted the devel-
PoliclinicoUniversitario,Messina,Italy;the5GlaxoSmithKlineS.p.A.,Verona,Italy;the6DiabetesUnit, opment of cardiovascular (CV) events
SpedaliCivili,Brescia,Italy;andthe7DiabetesUnit,OspedaleMadonnadelSoccorso,SanBenedettodel
during30months.
Tronto,AscoliPiceno,Italy.
Correspondingauthor:MariaC.E.Rossi,[email protected].
Received3September2010andaccepted29October2010.
RESEARCH DESIGN AND
DOI:10.2337/dc10-1709
This article contains Supplementary Data online at http://care.diabetesjournals.org/lookup/suppl/doi:10. METHODS
2337/dc10-1709/-/DC1.
*AcompletelistoftheAMD-QUASARStudyGroupcanbefoundintheSupplementaryData.
The Italian health care system
©2011bytheAmericanDiabetesAssociation.Readersmayusethisarticleaslongastheworkisproperly
cited,theuseiseducationalandnotforprofit,andtheworkisnotaltered.Seehttp://creativecommons.org/ AllItaliancitizensarecoveredbyagovern-
licenses/by-nc-nd/3.0/fordetails. ment health insurance and are registered
care.diabetesjournals.org DIABETESCARE,VOLUME34,FEBRUARY2011 347
QualityofdiabetescareandCVevents
with a general practitioner (GP). Primary Table1—Quality-of-care scoringsystem eye examination, although representing
care for diabetes is provided by GPs and key components of diabetes care, were
diabetesoutpatientclinics(DOCs).Patients not considered, since information was
Quality-of-careindicator Scoring
can choose one of these two ways of reported in nonstandardized format in
accessing the health care system or they HbA medicalrecords.
1c
can be referred to DOCs by their GPs. Measurement,1/year 5
WithintheItalianhealthcaresystemmore $8.0% 0
than600DOCsareinoperation. ,8.0% 10 Incident CV events
Information on CV events that occurred
Bloodpressure
Study design Measurement,1/year 5 over three years was collected. The pri-
This observational longitudinal study Values$140/90mmHg, mary composite end point was repre-
sented by total CV events, including
involved DOCs adopting an electronic irrespectiveoftreatment 0
medical record system for the routine Values,140/90mmHg 10 angina,myocardialinfarction(MI),stroke,
managementofoutpatients. Lipidprofilemeasurement,1/year 5 transientischemicattack,coronaryrevas-
cularizationprocedures,lower-limbcom-
Eachcenterwasaskedtoenrollupto LDLcholesterol,mmol/L(130mg/dL)
100patients,selectedamongindividuals $3.37,irrespectiveoftreatment 0 plications (claudication, ulcer, gangrene,
havingascheduledvisitduring6months, ,3.37 10 amputation,aortic-femoralrevasculariza-
using random sampling lists. Eligible in- MAmeasurement,1/year 5 tionprocedures),andCVmortality.
Secondary end points were repre-
dividuals were men andwomen patients NottreatedwithACEinhibitors/ARBs
with type 2 diabetes mellitus, aged $18 despitethepresenceofMA 0 sented by major CV events (nonfatal
MI, nonfatal stroke, CV mortality), MI,
years, irrespective of diabetes treatment TreatedwithACEinhibitors/ARBsin
cardiac revascularization procedures,
and duration. Newly diagnosed patients thepresenceofMAorMAabsent 10
were not included. At baseline, clinical Scorerange 0–40 stroke, lower-limb complications, CV
deaths,andtotaldeaths.
data were automatically extracted from MA,microalbuminuria;ARBs,angiotensinreceptor MIwasdefinedbasedonthepresence
electronic clinical records using an ad blockers.
ofatleasttwoofthefollowing:1)typical
hoc software. Information on CV events
ischemic chest pain, pulmonary edema,
thatoccurredduringthreeyearswascol- After having developed the score in the syncope, or shock; 2) development of
lected on ad hoc case report forms QuED (Quality of Care and Outcomes
pathological Q-waves and/or appearance
(Supplementary Fig. A1). All the data in Type 2 Diabetes) study, we have em-
or disappearance of localized ST-eleva-
wereanalyzedanonymously,andpatients piricallytestedthisaspectintheQUASAR
wereidentifiedonlybyanumericcode. study,wherewehavealsocollectedblood tion followed by T-wave inversion in
two or more of twelve standard electro-
Patients were enrolled between Jan- samples, which were centrally analyzed. cardiographleads;and 3)increase inthe
uary 2006 and November 2007 and From thesedata itemerged that patients
concentration of serum enzymes consis-
followed up until September 2009. The monitoredlessfrequentlytendedtohave
tentwithMI.
studywasapprovedbylocalethicscom- lower HbA1c and lipid levels and were Strokewasdefinedonthebasisofthe
mitteesofallparticipatingcenters. markedly less likely to have microalbu-
presence of unequivocal signs or symp-
minuria. tomsoffocalorglobalneurologicdeficit,
Quality-of-care summary score Toavoidastrictdependencefromthe
with sudden onset, lasting more than
Aquality-of-caresummaryscore(Table1), data,thescoresattributedtoeachprocess
24h,andconsideredofvascularorigin.
developed and validated in a previous and outcome measure were decided a
The following criteria were adopted
sptoupduyla(t1io4n),towacsonafiprpmlieidtstaobitlihtyetQoUpAreSdAicRt pfrroimoriraengdrenssoiotnbamseoddoenlswaepipglhietsddteorivthede to define CV death: death occurring
within 28 days after the onset of the
theincidenceofmajorvascularevents. data. Overall, the quality score ranges
documented diagnosis of MI or stroke,
Thescoreincludesthoseprocessand between 0 and 40, with a higher score
intheabsenceofanyotherevidentcause;
intermediate indicators for which a clear reflectingbetterqualityofcare.Thescor-
suddendeaths;deathsfromheartfailure;
link with vascular complications was ing system was applied to the data col- and all other deaths classified as cardio-
demonstrated and effective preventive lected at study entry and tested as a vascular (International Classification of
strategiesareavailable. predictorofincidentCVevents.Indica- Disease,ninthedition,ClinicalModifica-
For each item, the highest score was tors were calculated using the last in-
tion). The absence of any evident non-
assigned when the desired goals was formation relative to the 12 months cardiovascular cause was sufficient to
attained,whereasthelowestscorewasas- precedingtherecruitment.Becausenor- defineadeathascardiovascular.
sfoigrntehdeswpheceinficthceonpdatitieionntdweasspinteotelterveaatteedd mvaariledraanmgeosngfodriffgelryecnattceedntheresm,tohgelopbeirn- Alloftheeventswerecertifiedbythe
participatingcliniciansandwerebasedon
values or when the patient showed un- cent change with respect to the upper
clinical documentation. Patients were
satisfactory values despite the treatment. normal value (actual value/upper nor-
contacted by phone if their last visit to
Monitoring HbA , blood pressure, lip- mallimit)wasestimatedandmultiplied
1c the center had occurred more than 6
ids, or microalbuminuria less frequently by6.0.
monthsbefore.
than onceayear was attributedan inter- LDLcholesterolwasestimatedbythe
mediate scoring under the assumption Friedwald equation. The score only in-
that these parameters could be less fre- cluded those indicators that could be Statistical analysis
quently monitored in individuals with easily retrieved from medical records. Basedontheresultsofthepreviousstudy,
lessseverediabetesandinbettercontrol. Additional indicators, such as foot or thequalityscorewascategorizedinthree
348 DIABETESCARE,VOLUME34,FEBRUARY2011 care.diabetesjournals.org
RossiandAssociates
classes; however, because of a general Table2—Patientcharacteristics accordingtoquality-of-care score
trend of improvements in the average
qualityofcareinthelastyears,thecutoffs
Quality-of-carescore
ofthemiddleclasswereshiftedaheadby
5 points (,15, 15–25, .25). Patients’ Characteristic ,15 15–25 .25 P*
characteristics according to score classes N(%) 345(6.6) 3,531(68.2) 1,305(25.2)
werecomparedusingthex2testforcate-
Sex(%men) 51.6 57.8 61.8 0.001
gorical variables and the Kruskal-Wallis Age(years) 64.768.9 64.969.2 63.069.6 ,0.0001
one-way ANOVA for continuous vari- BMI(kg/m2) 30.765.2 29.965.0 29.264.8 ,0.0001
ables. Smoking ,0.0001
Incidence rates (IR) by score classes
No 66.5 61.8 51.6
were expressed in terms of events per
Ex 16.3 16.9 21.2
1,000person-years.
Yes 17.3 21.3 27.3
ProbabilitiesofCVeventaccordingto Diabetesduration(years) 11.968.5 10.268.7 9.168.0 ,0.0001
score classes were calculated using the Treatment ,0.0001
Kaplan-Meiermethodandcomparedus-
Dietalone 0.7 7.7 10.2
ingthelog-ranktest.AllreportedPvalues
Oralagents 60.6 68.5 72.0
aretwo-sided. Insulin6oralagents 38.7 23.8 17.8
To account for the multilevel nature
PreviousCVevent 20.0 18.9 21.3 0.18
of the data (patients clustered within HbA (%) 9.161.3 7.561.4 6.861.0 ,0.0001
1c
diabetes clinic), and to control simulta-
Bloodpressure(mmHg)
neously for the possible confounding Systolic 152.2615.4 144.9617.0 128.1613.6 ,0.0001
effects of the different covariates, we Diastolic 85.669.4 82.669.2 77.367.5 ,0.0001
used multilevel Poisson regression mod-
Cholesterol(mg/dL)
els to investigate whether the score was Total 224.3641.2 193.5639.9 177.3 ,0.0001
anindependentpredictorofCVevents LDL 152.3628.1 115.0635.0 100.2625.2 ,0.0001
incidence (15). In multilevel analyses HDL 50.8611.6 51.6613.2 50.4613.3 0.03
patient-related characteristics were tested Triglycerides(mg/dL) 174.96107.5 146.66126.73 138.1682.8 ,0.0001
as level 1 variables, whereas setting-
Dataarepercentagesormean6SD.*Pvaluesrefertox2forcategoricalvariablesandKruskal-Wallisone-way
related characteristics represented level 2
ANOVAforcontinuousvariable.
variables. The following patients’ charac-
teristics were tested: age, sex, BMI, dura-
tion of diabetes and treatment, smoking, treatedwithinsulinascomparedwithpa- scoreof,15andbetween20and25,re-
andhistoryofpreviousCVevent.Therisk tientsintheothertwoscoreclasses. spectively, compared with a score of
ofCVeventsaccordingtothescoreclasses During the follow-up, 477 (9.2%) .25). The same trend of association
was expressed in terms of incidence rate patients developed one or more CV was found for most of the outcomes,
ratio (IRR) and 95% confidence inter- events. The CV event rate was strictly although statistical significance was
vals (95% CIs), with a score of .25 as related to the score, being of 62.1 per reached for lower limb complications
thereferencecategory. 1,000 person-years in patients with a only (Fig. 2). The strong correlation be-
Finally, we estimated the intraclass score of ,15, 41.0 per 1,000 person- tweenthescoreofqualityofcareandCV
correlation coefficient (ICC) using the years in those with a score between 15 events was evident in patients without
score as dependent variable to evalu- and25,and36.7per1,000person-years previous CV events as well as in those
ate the extent to which the score varies inthosewithascoreof.25.Unadjusted who had already experienced a previous
between centers as compared with Kaplan-Meiercurvesshowthatascoreof event(SupplementaryTableA1).
within-center variation, taking patient ,15 was associated with a significant Finally,themeanqualityscorevaried
case-mix into account (16). The higher higher likelihood to develop a CV event substantiallyacrosscenters(from16.56
theICC,thegreatertheinfluenceofthe (Fig.1). 7.5to29.166.3).Meanqualityscoreby
physician-level on the quality-of-care Multilevelanalysis,adjustedforclus- center,adjustedforpatientcharacteristics
score. tering,age,sex,BMI,durationofdiabetes, andclusteringeffect,isinSupplementary
smoking, and history of CV event, Fig.A2.Whenthescorewastestedasthe
RESULTS—The study was conducted showed that the risk to develop a new dependentvariable,itemergedthat25%
in67diabetesclinics,and5,181patients CV event was 84% greater in patients ofthe varianceinthescore (ICC =0.25)
wereenrolled andfollowedup forame- withascoreof,15(IRR=1.84;95%CI couldbeattributedtobetweencentervar-
dian of 28 months (interquartile range 1.29–2.62) and 17% higher in those iation (i.e., to setting characteristics).
24–31). Overall, 6.7% of the patients with a score between 15 and 25 (IRR = When adjusting for case-mix (age, sex,
had a score of ,15, 68.2% had a score 1.17; 95% CI 0.93–1.49), as compared BMI, duration of diabetes, previous CV
between 15 and 25, and 25.1% had a with those with a score of .25. A trend events), variance attributable to center-
scoreof.25.Patients’characteristicsac- of increasing overall mortality according level characteristics remained elevated
cording to the score classes are reported tothequalityscorewasalsodocumented, (ICC=0.18).
inTable2.Patientswiththelowestscore although statistical significance was not
had a longer diabetes duration, and a reached (IRR = 1.68; 95% CI 0.78–3.63 CONCLUSIONS—Improving health
larger percentage of them were already andIRR =1.35; 95% CI 0.83–2.21fora outcomesistheultimategoalofthehealth
care.diabetesjournals.org DIABETESCARE,VOLUME34,FEBRUARY2011 349
QualityofdiabetescareandCVevents
Figure1—Event-freesurvival;allpatientsbygroupscore.
care system and should represent the otherside,alargeproportionofpatients standardized approaches could lead to
main aim for any quality measurement (i.e., 68.2%) lies in the 15–25 score sizeable savings in care and outcomes,
program. From the data on more than range, associated with a nearly 20% in- particularlyfocusingtheattentiononthe
5,000 patients with type 2 diabetes mel- creased risk of major events. A sub- largeproportionofpatientsfallinginthe
litusroutinelycaredforbydiabetesclinics stantially greater benefit could thus be intermediatecategoryofthescore.
and followed up for a median of 28 expected by improving the monitoring The possibility of calculating the
months, we confirmed that a quality-of- and treatment of major cardiovascular quality score from electronic medical re-
caresummaryscore,basedonarestricted risk factors in such a large population. cordsinaneasyandquickwaymakesits
number of indicators, is able to predict The score can help identifying patients useparticularlyappealing.Byallowingits
total cardiovascular events. The trend of whosequalityofcareissuboptimaland automaticcalculation,thescorecouldbe
increase in the event rates with the pro- inwhichaspects ofcareneedtobeim- used not only to identify patients at risk
gressivereductionofthescoreisclearfor proved. for poor quality of care but also to
alltheselectedoutcomes,includingover- Reducingvariationinhealthcarede- monitor the performance of the center
all mortality, although statistical signifi- liveryrepresentsakeycomponentofany across the years. The score can also be
cancewasnotreached. quality improvement initiative (18). In used for multicenter, continuous quality
Our study substantially reproduces ourstudy,meanqualityscorewidelydif- improvement initiatives by providing a
the body of evidence emerged by the fered among centers. It has been argued benchmarktowhichtocompareindivid-
QuEDstudy(14),confirmingthevalid- that process and intermediate outcomes ual performance. This approach is being
ity and applicability of the instrument. canbeaffectednotonlybymedicalinter- adoptedinthecontextofawidenational
In comparison with previous studies ventionsbutalso bypatientfactors(19); initiative in Italy, involving over 250 di-
(14,17), conducted ten years ago in inotherwords,thescoremightreflectpa- abetes clinics for a total of half a million
comparable settings, quality of care has tient variation rather than disparities in patients. The score will be calculated at
improved,asreflectedbythelowerper- thequalityofcare.Weshowedthatarel- the national, regional, and individual
centageofpatientsscoringbelow15and evantproportionoftotalvariancewasex- centerlevels,andtheoverallperformance
the general shift of the score distribution plained by center-level characteristics will be measured against that of the best
towardhighervalues.Patientswithapar- (16), even after adjusting for patient performers.
ticularly high risk of negative outcomes, case-mix.Tothisrespect,thescoreseems Some of the potential limitations of
i.e., those with a score of ,15, now to efficiently capture differences in the our study need to be discussed. First,
representasmallminority(6.7%).Acting performanceofthecenters.Thewidevar- physicians were selected according to
toimprovetheperformanceinthissmall iationinhealthcaredeliverystronglysug- their willingness to participate. They
subgroupwouldhardlytranslateintotan- gests that a substantial proportion of could thus represent those clinicians
gible results at the population level, al- cardiovascular events could be avoided more interested in diabetes care and
though individual patients would benefit byprovidinghigherqualityandmoreho- therefore not reflect the diabetes care
from any quality improvement. On the mogeneouslevelsofcare.Theuseofmore delivered by Italian physicians. It is thus
350 DIABETESCARE,VOLUME34,FEBRUARY2011 care.diabetesjournals.org
RossiandAssociates
DiabetesAssociation,Orlando,Florida,25–29
June2010.
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