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Effect on Quality of Life of Different Accelerated DiagnosticProtocols for Management of Patients Presenting to the Emergency

Department With Acute Chest Pain

Gaetano Nucifora, MD, Luigi P. Badano, MD*, Nizal Sarraf-Zadegan, MD,Apostolos Karavidas, MD, Giuseppe Trocino, MD, Giorgio Scaffidi, MD, Giacinto Pettinati, MD,

Costantino Astarita, MD, Vitas Vysniauskas, MD, Dario Gregori, PhD, Baris Ilerigelen, MD,and Paolo M. Fioretti, MD, PhD

This study assessed the effects on quality of life (QoL) of dobutamine-atropine stressechocardiography (DASE) and electrocardiogram exercise testing (EET) accelerated diag-nostic protocols for early stratification of low-risk patients with acute chest pain (ACP). Atotal of 290 patients with ACP, a nondiagnostic electrocardiogram, and negative biomar-kers were randomly assigned to an accelerated diagnostic protocol (DASE, n � 110, orEET, n � 89) or usual care (n � 91) and followed up for 2 months. QoL was assessed atdischarge and 2-month follow-up using the Nottingham Health Profile questionnaire.Baseline and 2-month follow-up answers to the Nottingham Health Profile questionnairewere available for 207 patients (71%; 55 in the usual-care, 77 in the DASE, and 75 in theETT arm). At predischarge, patients in the usual-care arm reported higher impairment inthe physical mobility and pain dimensions compared with the DASE and EET arms (p �0.019 and p � 0.023, respectively). At 2-month follow-up, QoL improved in all groups;however, patients in the usual-care arm had significantly worse scores than patientsmanaged using accelerated diagnostic protocols in the physical mobility, pain, socialisolation, emotional reactions, and energy level dimensions (p � 0.014, p � 0.002, p � 0.04,p � 0.01, and p � 0.003, respectively). In conclusion, low-risk patients with ACP hadnon-negligible impairment of QoL in the acute phase. Emergency department ADPs withearly DASE and EET reduced QoL impairment at both baseline and 2-month

follow-up. © 2009 Elsevier Inc. (Am J Cardiol 2009;103:592–597)

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Accelerated diagnostic protocols implementing stressests for early stratification of low-risk patients presenting tohe emergency department with acute chest pain (ACP)ave been previously validated as feasible, safe, and cost-ffective.1–13 However, their influence on quality of lifeQoL) has been poorly investigated. Medical care interven-ions should meet a standard of patient acceptability inddition to fulfilling biomedical and physiologic standards.he aim of this prospective randomized multicenter trialas to assess effects of 3 management strategies on QoL ofatients needing admission for evaluation of ACP: dobu-amine-atropine stress echocardiography (DASE) and elec-rocardiogram exercise testing (EET) accelerated diagnosticrotocols and usual clinical, electrocardiographic, and bio-umoral workup (usual care).

ethods

The Assessment of cost-effectiveness of Several Strate-ies of Early diagnosis in patients with ACP and Non-

Istituto per la Ricerca Clinica Applicata e di Base (IRCAB) Founda-ion, Udine, Italy. Manuscript received September 28, 2008; revised manu-cript received and accepted October 24, 2008.

*Corresponding author: Tel: �39-43-255-2441; fax: �39-43-248-2353.

pE-mail address: badano.luigi@aoud.sanita.fvg.it (L.P. Badano).

002-9149/09/$ – see front matter © 2009 Elsevier Inc.oi:10.1016/j.amjcard.2008.10.030

onclusive Electrocardiogram (ASSENCE) Study was aarallel randomized trial carried out in 10 emergency de-artments of 5 different countries (Appendix). Exclusionnd inclusion criteria are listed in Table 1. Briefly, patientsho fulfilled inclusion and exclusion criteria and gave in-

ormed consent were randomly assigned to DASE, EET, orsual care. These patients with ACP were deemed to be atow risk because of a nondiagnostic electrocardiogram andegative myocardial injury biomarkers. According to thetudy protocol, both stress tests had to be performed within8 hours of randomization. All patients with negativeASE or EET results were immediately discharged after the

est. Patients with positive DASE or EET results were ad-itted to the coronary care unit. Patients enrolled in the

sual-care arm were hospitalized until a positive or negativeiagnosis was reached according to local protocols withoutmposing any time constraints on investigators. After dis-harge, patients were followed up for 2 months using tele-hone calls performed by a nurse or physician at 1 week, 1onth, and 2 months. Charts of all admitted patients were

eviewed to record cardiovascular procedures, complica-ions, and diagnoses.

The QoL substudy protocol is shown in Figure 1. Not-ingham Health Profile (NHP) QoL questionnaires weredministered to patients. The NHP14 is a 2-part instrument;

art I was used in this study. It assessed subjective health

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tatus by investigating the ability to carry out different dailyife activities. It comprised 38 statements divided into 6imensions: physical mobility (8 items), pain (8 items),ocial isolation (5 items), emotional reactions (9 items),nergy level (3 items), and sleep (5 items). For each state-ent, patients must answer “Yes” (there is a handicap) or

No” (no handicap). Each dimension was scored from 0 (noandicap) to 100 (major handicap); a score of 100 pointsepresented an extensive personal restriction. Patients weresked to complete the NHP questionnaire at hospital dis-harge and 2-month follow-up.

Analyses were performed according to the intention-to-

able 1atient selection criteria

Inclusion criteria1. ACP within the last 24 hours in absence of local trauma and

abnormalities on chest X-ray2. Nondiagnostic electrocardiogram at admission3. Negative myocardial injury biomarkers4. Ability to perform electrocardiogram exercise testing

Exclusion criteria1. Age �30 years2. Prehospital or emergency department complication of acute

ischemia or myocardial infarction:Cardiac arrest or ventricular arrhythmiaSyncopeHeart failureSystolic blood pressure �100 mm Hg

3. Premature ventricular beats �6/min4. Atrial fibrillation5. Dilated or hypertrophic cardiomyopathy6. Complex congenital heart disease7. Significant valvular disease8. Known aortic aneurism �50 mm9. Uncontrolled proven hypertension �180/100 mm Hg

10. Complete left branch bundle block

igure 1. Study protocol for the assessment of QoL. CK � creatine kinase;CG � electrocardiogram.

reat principle. Values were expressed as mean � SD. v

omparison between continuous variables was performedsing 1-way analysis of variance test. When the result ofnalysis was significant, the Dunn-Šidák post hoc test waspplied. Chi-square test for �2 � 2 and Fisher’s exact testor 2 � 2 contingency tables were computed to test forifferences in categorical variables. Repeated-measuresnalysis of variance was used to assess NHP score changesver time. Multivariate linear regression analysis (with step-ise selection procedure and retention level set at 0.1) waserformed to determine the independent correlations ofaseline NHP scores and NHP score change from baselineo the 2-month follow-up. Age, gender, arm of randomiza-ion, discharge diagnosis, pharmacologic treatment pre-cribed at discharge, and length of in-hospital stay were theariables entered in the first model. The same variables,ogether with rehospitalizations and additional diagnosticxaminations during follow-up, were entered in the secondodel. Arm of randomization was entered in the models

nly if a statistically significant difference in NHP scoresmong the 3 groups was found using 1-way analysis of

able 2emographic and clinical characteristics of study population

ariable Usual Care(n � 55)

DASE(n � 77)

EET(n � 75)

ge (yrs) 56 � 14 52 � 10 50 � 10en 30 (55%) 41 (53%) 51 (68%)

ast ACP attack (h)0–330 (55%) 36 (47%) 42 (56%)3–6 14 (25%) 16 (21%) 17 (23%)6–12 7 (13%) 18 (23%) 11 (15%)�12 4 (7%) 7 (9%) 5 (6%)CP on admission 38 (69%) 50 (65%) 53 (71%)CP characteristicsAtypical 8 (15%) 18 (23%) 18 (24%)Typical 47 (85%) 59 (77%) 57 (76%)ypertension 27 (49%) 29 (38%) 26 (35%)ypercholesterolemia

(total cholesterol�240 mg/dl)

22 (40%) 29 (38%) 20 (27%)

iabetes mellitus 6 (11%) 9 (12%) 5 (7%)moker 27 (49%) 37 (48%) 33 (44%)revious unstable angina

pectoris1 (2%) 1 (1%) 3 (4%)

revious myocardialinfarction

1 (2%) 2 (3%) 2 (3%)

revious coronaryarteriography

4 (7%) 2 (3%) 3 (4%)

revious percutaneouscoronaryintervention

3 (5%) 1 (1%) 2 (3%)

revious coronary arterybypass grafting

0 (0%) 1 (1%) 0 (0%)

harmacologic treatmentbefore admission

Nitrates 5 (9%) 8 (10%) 6 (8%)Antiplatelet drugs 12 (22%) 18 (23%) 12 (16%)� Blockers 7 (13%) 13 (17%) 7 (9%)Calcium channel

blockers6 (11%) 11 (14%) 6 (8%)

Values expressed as as mean � SD or number (percent).

ariance test. A p value �0.05 was considered statistically

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ignificant. Analyses were performed using SPSS statisticaloftware, 15.0 release (SPSS Inc., Chicago, Illinois).

esults

A total of 290 patients were randomly assigned to usualare (n � 91), DASE (n � 110), and EET (n � 89) manage-ent strategies. Both baseline and 2-month follow-up answers

o the NHP questionnaire were available for 207 patients (55 inhe usual-care, 77 in the DASE, and 75 in the EET arm).aseline characteristics of these patients are listed in Table 2.ean age was 53 � 11 years, and 122 (59%) were men.

hree-quarters of patients reported ACP at admission. The 3roups were similar with respect to most baseline characteris-ics, including ACP characteristics, prevalence of coronary riskactors, and previous cardiac procedures.

Table 3 lists final diagnoses recorded in clinical charts

able 3n-hospital clinical outcome, pharmacologic treatment prescribed at discha

ariable

schemic chest painonischemic chest painharmacologic treatment prescribed at dischargeNitratesAntiplatelet drugs� BlockersCalcium channel blockersdmission to discharge (h)Total patientsPatients discharged with diagnosis of ischemic chest painPatients discharged with diagnosis of nonischemic chest pain

Values expressed as mean � SD or number (percent).* p � NS between the DASE and EET arms.

able 4wo-month follow-up events and additional diagnostic examinations

ariable Usual Care(n � 55)

DASE(n � 77)

EET(n � 75)

pValue

ehospitalizations forACP

8 (15%) 2 (3%) 5 (7%) 0.03*

yocardialrevascularizations

2 (4%) 5 (6%) 6 (8%) NS

Percutaneouscoronaryinterventions

1 (2%) 4 (5%) 5 (7%)

Coronary arterybypass grafting

1 (2%) 1 (1%) 1 (1%)

dditional diagnosticprocedures

Transthoracicechocardiography

12 (22%) 1 (1%) 3 (4%) �0.001*

EET 13 (24%) 7 (9%) 4 (5%) 0.007*EDASE 2 (4%) 0 (0%) 0 (0%) NSCoronary

angiography6 (11%) 0 (0%) 3 (4%) 0.01*

Values expressed as number (percent).* p � NS between the DASE and EET arms.

fter hospital admission and pharmacologic treatment pre- t

cribed at discharge. Patients randomly assigned to usualare received more frequently a diagnosis of ischemic chestain, whereas those randomly assigned to DASE and EETeceived more frequently a diagnosis of nonischemic chestain, according to results of stress tests (p �0.001). Ofatients randomly assigned to usual care, the final diagnosisas achieved using clinical judgment only without perform-

ng additional diagnostic examinations in 39 cases (71%),sing DASE in 6 (11%), using EET in 7 (13%), and usingoronary angiography in 3 (5%). Length of in-hospital stayn patients discharged with a diagnosis of nonischemic chestain was significantly longer in those assigned to usual carehan those assigned to the DASE or EET arm (Table 3). Non-hospital cardiovascular event (death or acute myocardialnfarction) was observed.

No cardiovascular events occurred during follow-up, and

d length of in-hospital stay

l Care55)

DASE(n � 77)

EET(n � 75)

p Value

49%) 13 (17%) 17 (23%) �0.001*51%) 64 (83%) 58 (77%) �0.001*

22%) 10 (13%) 12 (16%) NS44%) 23 (30%) 25 (33%) NS29%) 16 (21%) 17 (23%) NS24%) 16 (21%) 14 (19%) NS

74 40 � 42 39 � 35 �0.001*77 89 � 51 82 � 49 NS57 22 � 14 30 � 24 �0.001*

able 5ean Nottingham Health Profile scores at discharge and 2-month

ollow-up

ariable Usual Care(n � 55)

DASE(n � 77)

EET(n � 75)

pValue

ischargePhysical mobility 37 � 32 26 � 23 24 � 27 0.019Pain 35 � 33 25 � 26 20 � 30 0.023Social isolation 29 � 36 19 � 30 18 � 32 NSEmotional reactions 34 � 31 27 � 26 26 � 30 NSEnergy level 47 � 41 38 � 39 31 � 38 NSSleep 38 � 31 41 � 31 35 � 30 NS-Month follow-upPhysical mobility 22 � 19* 15 � 16* 14 � 16* 0.014Pain 15 � 19* 7 � 10* 6 � 14* 0.002Social isolation 11 � 16* 4 � 9* 6 � 17† 0.04Emotional reactions 29 � 30‡ 21 � 25‡ 14 � 23† 0.01Energy level 21 � 21* 14 � 14* 11 � 16* 0.003Sleep 20 � 15† 22 � 17† 23 � 22† NS

Values expressed as mean � SD. p � NS for all comparisons betweenhe DASE and EET arms.

* p �0.001, discharge versus follow-up.† p �0.01, discharge versus follow-up.‡ p � NS, discharge versus follow-up.

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595Coronary Artery Disease/QoL and ACP Diagnostic Protocols

percutaneous coronary intervention or coronary artery by-ass grafting) was similar in the 3 groups. However, pa-ients randomly assigned to usual care were more frequentlyehospitalized for ACP and more commonly underwent

igure 2. (A–F) Changes over time in NHP scores. Continued gray line, uvalue for group effect � NS between the DASE and EET arms.

dditional diagnostic examinations (Table 4). i

Table 5 lists predischarge and 2-month follow-up NHPcores. There was impairment in health-related QoL on all

dimensions before discharge after the index admission.atients randomly assigned to usual care reported higher

e arm; continued black line, DASE arm; dotted black line, EET arm. The

sual-car

mpairment in the physical mobility and pain dimensions of

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596 The American Journal of Cardiology (www.AJConline.org)

oL compared with patients managed using the acceleratediagnostic protocols (p � 0.019 and p � 0.023, respec-ively). Multivariate linear regression analysis identifiedandomization to usual care as the only variable signifi-antly related to impairment in the physical mobility (� �.27, p �0.001) and pain dimensions (� � 0.25, p � 0.001).ischarge diagnosis of ischemic chest pain was the onlyariable significantly related to impairment in the socialsolation dimension (� � 0.19, p � 0.012). Female gendernd discharge diagnosis of ischemic chest pain were thenly variables significantly related to impairment in thenergy level dimension (� � 0.21, p � 0.006, and � � 0.17,� 0.026, respectively). Age and female gender were the

nly variables significantly related to impairment in theleep dimension (� � 0.17, p � 0.024, and � � 0.22, p �.003, respectively).

At the 2-month follow-up, significant improvement inHP scores was observed in all 3 groups (Figure 2). How-

ver, patients randomly assigned to usual care showed sig-ificantly worse scores in the physical mobility (p � 0.014),ain (p � 0.002), social isolation (p � 0.04), emotionaleactions (p � 0.01), and energy level (p � 0.003) dimen-ions compared with patients managed according to DASEr EET results, indicating higher impairment in such aspectsf daily life (Table 5). Multivariate linear regression anal-sis identified discharge diagnosis of nonischemic chestain as the only variable significantly related to improve-ent in the physical mobility (� � �0.19, p � 0.012) and

ocial isolation dimensions (� � �0.15, p � 0.044). Ageas the only variable significantly related to improvement

n energy level dimension (� � �0.15, p � 0.045), whereasemale gender was the only variable significantly related tomprovement in the sleep dimension (� � �0.17, p �.032).

iscussion

Our study showed that low-risk patients admitted to themergency department with ACP had non-negligible im-airment in QoL in the acute phase that improved in allimensions during the next 2 months. Accelerated diagnos-ic protocols with early DASE or EET for emergency de-artment triaging of these patients decreased QoL impair-ent at both baseline and the 2-month follow-up comparedith usual care.Previous studies of early stress tests for triaging low-risk

atients with ACP focused on cardiac events and economiceasures, validating them as safe and cost-effective,1–13

hereas their effects on QoL have been poorly investiga-ed15,16 despite substantial data suggesting that this was anmportant issue for patients.17–19

Anxiety and psychological morbidity were frequent inatients presenting to the emergency department withCP17,18 and were associated with impaired QoL.15,16 Thisas also confirmed by our data. At predischarge, studyatients had non-negligible impairment in all 6 aspects ofhe subjective health status evaluated in the NHP question-aire. The presence of suspected acute coronary syndromeppeared to handicap several aspects of QoL and interfere

ith basic daily activities, preventing physical mobility and g

leep, causing a decline in energy, and arising emotionaleactions of fear and depression.

Our study also showed that low-risk patients with ACPxperienced psychological benefits using an accelerated di-gnostic workup with early DASE or EET that allowed anmmediate discharge in case of negative stress test resultsompared with usual care. The benefit provided by theccelerated diagnostic protocols was already visible at pre-ischarge and was maintained during follow-up, althoughignificant improvement in QoL was observed in all 3roups after 2 months. Diagnostic uncertainty may be anmportant reason for this finding. In the usual-care arm,iagnosis was performed using clinical means alone withoutdditional diagnostic examinations during the index admis-ion in 71% of patients. This conservative approach led torolonged hospitalization and was probably responsible forrotracted concern of patients about their health status.urthermore, lack of a diagnosis based on clear objectivendings of the presence or absence of myocardial ischemiaay also have led to further rehospitalizations and frequent

dditional diagnostic examinations during follow-up. Un-ertainty and inadequate information about the origin ofain may have caused feelings of insecurity and anxiety inatients, with subsequent impairment in QoL. Conversely, aegative stress test result during the initial assessment ofCP can quickly rule out the presence of ischemic heartisease and reassure patients about their health status andunctional integrity, reducing anxiety about their symptomsnd uncertainty about their illness.20

This study had a few limitations that should be acknowl-dged. Baseline and 2-month follow-up answers to the NHPuestionnaire were available for 71% of patients enrolled inhe main study. Uncertainty could remain about whether ouresults would be affected differently if nonresponders hadlso taken part in the assessment of QoL. Therefore, weompared the 83 patients for whom answers to the NHPuestionnaire were not available with the study populationegarding clinical outcomes and other variables looking forifferences that could influence our results. The proportionsf patients with a diagnosis of ischemic or nonischemichest pain were similar, and the 2 groups did not differ forther demographic and clinical factors. Nevertheless, therevalence of patients randomly assigned to usual care wasignificantly higher in nonparticipants in the QoL assess-ent. It is possible that if these patients had taken part in the

ssessment of QoL, our results would have been furthertrengthened.

Another limitation related to the inability to blind pa-ients to the intervention they received. Subjects may haveeen influenced and improvements in QoL may represent aositive response to receiving a novel form of care, ratherhan improvements specifically related to the acceleratediagnostic protocols.

ppendix

Enrolling centers and local investigators: Greece: Athenseneral Hospital, Athens (Apostolos Karavidas); Italy: Uni-ersity Hospital S. Maria della Misericordia, Udine (Luigi. Badano, Paolo M. Fioretti, Gaetano Nucifora, Gianau-

usto Slavich); San Gerardo Hospital, Monza (Giuseppe

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597Coronary Artery Disease/QoL and ACP Diagnostic Protocols

rocino); S. Filippo Neri Hospital, Rome (Giorgio Scaffidi);. Giacomo Hospital, Castelfranco Veneto (Alessandro De-ideri); F. Ferrari Hospital, Casarano (Giacinto Pettinati);orrento Hospital, Sorrento (Costantino Astarita); Iran:niversity of Medical Sciences, Isfahan (Nizal Sarraf-Zade-an); Lithuania: Marijampole Central Hospital, Marijam-ole (Vitas Vysniauskas); Turkey: Istanbul University,stanbul (Baris Ilerigelen).

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