Rhinitis, sinusitis, and upper airway disease

Validation of the first treatment-specific questionnaire forthe assessment of patient satisfaction with allergen-specificimmunotherapy in allergic patients: The ESPIAquestionnaire

Jos�e Luis Justicia, MD, PhD,a Victoria Cardona, MD,b Pedro Guardia, MD,c Pedro Ojeda, MS,d Jos�eMar�ıa Olagu�ıbel, MD,e

Jos�e Mar�ıa Vega, MD,f Carmen Vidal, MD,g Eva Bar�o, MSc,h and Mario Alberto Garc�ıa, PhDa Barcelona, Seville, Madrid,

Pamplona, M�alaga, and Santiago de Compostela, Spain

Background: Satisfaction with treatment is a patient-reportedoutcome shown to be associated with the patient’s health-relateddecisions and treatment-related behavior, thereby influencing thechances of successful treatment, and is especially relevant in long-term treatment, such as allergen-specific immunotherapy (AIT).Objective: We sought to assess the psychometric properties ofthe Satisfaction Scale for Patients Receiving AllergenImmunotherapy (ESPIA) questionnaire so as to determine thesatisfaction of patients receiving AIT treatment.Methods: An observational, longitudinal, multicenter study wasperformed on patients with allergic rhinitis (AR) undergoingAIT treatment. Sociodemographic, clinical, and patient-centered health outcomes data were gathered at the study visits.Feasibility, reliability, validity, and sensitivity to change of theprevalidated version of the ESPIA questionnaire were assessed.Results: Four hundred twenty-nine patients were included(52.2% women, 33.6 years of age, 54.5% of the cases withintermittent AR and 62.5% with moderate AR). Low levels ofmissing items and ceiling/floor effects were found for the overallscore of the ESPIA questionnaire. The overall Cronbach a valueand intraclass correlation coefficient were 0.90 and 0.92,respectively. The overall score for the ESPIA questionnaire was

From athe Medical Department, Stallergenes Ib�erica, Barcelona; bHospital Universitari

Vall d’Hebron, Barcelona; cHospital Universitario Virgen Macarena, Seville; dCl�ınica

de Asma y Alergia Dres, Ojeda, Madrid; eComplejo Hospitalario de Navarra,

Pamplona; fHospital Regional Universitario Carlos Haya, M�alaga; gComplejo Hospi-

talario Universitario de Santiago, Santiago de Compostela; and hthe Health Outcomes

Research Department, 3D Health Research, Barcelona.

Supported by Stallergenes Ib�erica, S.A.

Disclosure of potential conflict of interest: J. L. Justicia and M. A. Garc�ıa are employed

by Stallergenes Ib�erica. V. Cardona and C. Vidal have consultant arrangements with

and have received travel support from Stallergenes. P. Guardia has received grants and

consulting fees from Stallergenes. P. Ojeda is on the advisory board for Stallergenes,

has consultant arrangements with ALK-Abell�o and Reig Jofre, and has received grants

from Diater Laboratories and Allergopharma. J. M. Olagu�ıbel has received travel sup-

port and fees for participation in review activities from Stallergenes. J. M. Vega has

consultant arrangements with and has received travel support from Stallergenes

Iberica. E. Bar�o has received fees for participation in review activities and payment

for writing or reviewing this manuscript from 3D Health Research.

Received for publication February 24, 2012; revised November 12, 2012; accepted for

publication November 26, 2012.

Available online January 23, 2013.

Corresponding author: Mario Alberto Garc�ıa, PhD, Product Specialist, Stallergenes Ib�er-

ica, S.A., C/Ramon Turr�o 91, Bajos, 08005 Barcelona, Spain. E-mail: mgarciag@

stallergenes.es.

0091-6749/$36.00

� 2013 American Academy of Allergy, Asthma & Immunology

http://dx.doi.org/10.1016/j.jaci.2012.11.049

strongly associated with months receiving AIT, AR type andintensity, presence of conjunctivitis, self-perceived health status,effect of AR on daily life, and expectations about the AITtreatment. The pattern of correlations obtained with otherpatient-centered health outcomes was consistent withexpectations. The ESPIA questionnaire also showed goodsensitivity to change for improved health status.Conclusion: The ESPIA questionnaire to assess patientsatisfaction with respect to AIT treatment presented satisfactorypsychometric properties for its use in clinical practice.(J Allergy Clin Immunol 2013;131:1539-46.)

Key words: Allergy, allergen-specific immunotherapy, satisfaction,questionnaire, validation, reliability

Patient-reported outcomes, particularly measures of patientpreference, should play a central role in the planning and deliveryof medical care. Patient satisfaction, a subclass of patient-reported outcome measures, has been used extensively to includepatients’ perceptions of care when evaluating the effectiveness ofmedical treatments and systems of health care delivery.1-4

Patient satisfaction has been shown to affect patients’ health-related decisions and treatment-related behaviors, which in turnhave a substantial effect on the success of treatment outcomes. Forexample, satisfactionwithmedication predicts correct medicationuse and compliancewithmedication regimens.5,6 On the contrary,dissatisfaction with treatment might act as an early warning ofthreats to the clinical effectiveness and efficiency of medical care.Allergen-specific immunotherapy (AIT) is a causative treat-

ment for allergic diseases with a well-documented clinicalefficacy.7-10 However, as occurs in many treatments for long-term or chronic illnesses, its effectiveness can be endangered byadherence problems related to diverse factors, such as discomfortassociated with treatment administration, complexity of adminis-tration guidelines, perception of a lack of efficacy at treatment in-itiation, and adverse effects.11,12

Within this context, knowledge of patient satisfaction with AITcould provide the physician with very useful information thatwould contribute to better clinical management and be moreadapted to the patients’ needs and preferences, therefore havinggreater possibility of success.There already exist satisfaction measurement instruments on

the treatment of certain illnesses and symptoms,13-18 as well asmore generic instruments to assess satisfaction with chronic

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1540 JUSTICIA ET AL

Abbreviations used

AIT: A

llergen-specific immunotherapy

AR: A

llergic rhinitis

ESPIA: S

atisfaction Scale for Patients Receiving Allergen

Immunotherapy

TSS4: T

otal Symptom Score

VAS: V

isual analog scale

treatments.4,19 However, at present, there exists no validatedquestionnaire on satisfaction with specific immunotherapy for pa-tients with allergic respiratory illnesses.The current article presents the outcomes of the preparation

process and validation of the ESPIA (Escala de Satisfacci�on dePacientes que reciben Inmunoterapia con Al�ergenos) [Satisfac-tion Scale for Patients Receiving Allergen Immunotherapy])questionnaire.

METHODS

Instrument developmentThe ESPIA questionnaire was developed by using multiple sources of data:

literature review, focus groups with allergic adults undergoing AIT, and

meetings with allergologists. Seventy potential items were administered to

257 allergic patients undergoing AIT in a cross-sectional study, and

item reduction was based on quantitative (clinimetric and psychometric

methods) and qualitative criteria. As a result, a 16-item, prevalidated, patient-

centered scale was obtained for the assessment of satisfaction with AIT.20

Validation studyParticipants and procedures. So as to assess the psychometric

properties of the first Spanish-language questionnaire on patient satisfaction in

those receiving AIT, an observational, prospective, and multicentered study

was conducted between the months of April and October 2010 in the allergy

centers of 42 health centers within Spanish territory. With the aim of testing

the main psychometric properties of the ESPIA questionnaire, 2 different

groups of patients were defined: one group with heterogeneous clinical

characteristics to test the transversal psychometric properties (mainly internal

consistency and construct validity; group A) and another group with a low

level of satisfaction with AIT at study commencement, which could presum-

ably improve over time, so as to test the longitudinal psychometric properties

(test-retest reliability and sensitivity to change; group B).

The participating investigators consecutively included adults with a

confirmed diagnosis of respiratory allergy who (1) were receiving uninter-

rupted sublingual or subcutaneous AIT for at least 6 months or during 2

preseasonal or precoseasonal cycles (group A) or (2) had started sublingual or

subcutaneous AIT 1 to 3 months before being included in the study (group B).

Moreover, the patients in group B had to present baseline satisfaction with

respect to the recently initiated AIT between low and moderate to be included

in the group, according to an ad hoc item administered for this purpose. All the

patients included in the study had to be able to understand and answer the

questions in the questionnaire that was administered to them without assis-

tance. Data gathering was performed only once for group A, during the study

inclusion visit, whereas data gathering was prospective for group B and per-

formed at commencement (the inclusion visit) and after 7 to 10 days (retest

visit) and 4 months (final visit) of inclusion in the study.

The study was approved by the Ethics Committee of the Hospital

Universitari Vall d’Hebron in Barcelona before patient recruitment, and all

patients provided written informed consent before study enrollment.

Instruments.

ESPIA questionnaire. The newly developed ESPIA questionnaire

(see Tables E1 and E2 in this article’s Online Repository at www.jacionline.

org) is a self-administered disease-specific questionnaire for the assessment

of patient satisfaction with AIT. The details of development and prevalidation

of the ESPIA questionnaire have previously been described.20 The question-

naire consists of 16 items distributed in 4 dimensions: perceived efficacy, ac-

tivities and environment, cost-benefit balance, and general satisfaction. The

questionnaire scores (overall and for the 4 dimensions) are obtained by trans-

forming the sum of its items to a 0- to 100-point scale, with low scores indi-

cating worse satisfaction.

Total Symptom Score (TSS4). This score was used for the

assessment of allergic rhinitis (AR) symptom severity, which is defined as the

sum of nasal symptoms of obstruction, rhinorrhea, itching, and sneezing. Each

of these is scored on a scale from 0 to 3, resulting in a TSS4 score ranging from

0 (no symptoms) to 12 (maximum symptoms severity).21-23

ESPRINT-28. The ESPRINT-28 (cuestionario ESPa~nol de calidad de

vida en RINiTis [Spanish questionnaire of quality of life in rhinitis]) is a

28-item, self-administered, disease-specific, health-related quality-of-life ques-

tionnaire for patients with AR. An overall score is obtained that indicates the

greatest effect of AR on the patient’s quality of lifewhen said score is highest.23

Global ratings of satisfaction and other health out-

comes. AIT treatment satisfaction (‘‘Please mark with an ’X’ the point in

the scale that best represents your current satisfaction with the allergy

vaccine’’), energy level (‘‘How would you assess your energy level over the

last two weeks?’’), capacity for performing daily activities (‘‘How would you

assess your ability to perform daily activities over the last two weeks?’’), and

general quality of life (‘‘How would you assess your general quality of life

over the last twoweeks?’’) were assessed bymeans of four 100-mm horizontal

visual analog scales (VASs).

ESPIA questionnaire’s ease of use and time taken for

administration. Patients were also asked to rate the new questionnaire’s

ease of use on a scale of 7-point Likert options ranging from ‘‘very difficult to

complete’’ to ‘‘very easy to complete.’’ The time taken to complete the

questionnaire was also recorded.

Health status transition item. In group B a ‘‘health status

transition’’ item (‘‘Since the first study visit, 4 months ago, your health status

in relation to your allergy: - i.e. has improved a little –’’) was also self-

administered at the second (7-10 days) and third (after 4 months) visits to

assess changes in health status perception since the first visit. Patients provided

answers based on a Likert-type ordinal scale with 13 response options ranging

from ‘‘have greatly improved’’ to ‘‘have greatly worsened.’’ The results were

used in the analysis of test-retest reliability and sensitivity to change.

Clinical and sociodemographic data. Sociodemographic

data (sex, age, and level of education) and clinical basics (eg, time passed since

AR diagnosis, AR intensity, allergy history, medication treatment, and

aeroallergen causing AIT treatment) were gathered from the study patients.

Statistical analysisThe questionnaire’s feasibility was assessed by examining responses to

the ease-of-use question and the time taken to complete the questionnaire. The

missing information was also assessed by calculating the completion rate (the

percentage of respondents with no missing data in any of the 16 items) and

the range of missing answers (the maximum number of missing responses per

item).

The distribution of the overall and dimension scores was analyzed by

calculatingmeanscores,SDs, observedscore ranges, andfloor andceiling effects

(the proportion of patients with the worst and best possible scores, respectively)

for the overall score and for each dimension of the ESPIA questionnaire.

The instrument’s internal consistency was assessed by estimating Cron-

bach a24 coefficients for individual dimensions and the overall score at the

baseline. We expected to obtain a Cronbach a value of greater than 0.70, as

recommended in the literature.25,26 The 7- to 10-day test-retest reliability

was assessed by calculating the intraclass correlation coefficient between

visits among patients who did not report any significant change on the health

status transition item between the initial visit and the test-retest visit.

The construct validity of the ESPIA questionnaire was assessed. In

particular, the known-groups validity was tested by determining whether the

instrument was able to discriminate between patient groups likely to differ in

TABLE I. Baseline characteristics of the study sample (n 5 429)

Variable Group A (n 5 335) Group B (n 5 94) Overall sample (n 5 429)

Age (y), mean (SD) 33.4 (10.7) 34.7 (11.6) 33.6 (10.9)

Sex, no. (%)

Male 165 (49.3) 39 (41.5) 204 (47.6)

Female 170 (50.7) 54 (57.4) 224 (52.2)

Educational level, no. (%)

No formal education 8 (2.4) 0 (0) 8 (1.9)

Primary education 50 (14.9) 18 (19.1) 68 (15.9)

Secondary education 144 (43.0) 38 (40.4) 182 (42.4)

University or similar 131 (39.1) 37 (39.4) 168 (39.2)

Time from diagnosis (y), mean (SD) 6.4 (5.3) 6.9 (6.9) 6.5 (5.7)

Type of AR, no. (%)

Intermittent* 152 (45.4) 38 (40.4) 190 (44.3)

Persistent� 178 (53.1) 56 (59.6) 234 (54.5)

AR classification (according to Valero�), no. (%)

Mild 62 (18.5) 8 (8.5) 70 (16.3)

Moderate 202 (60.3) 66 (70.2) 268 (62.5)

Severe 68 (20.3) 20 (21.3) 88 (20.5)

TSS4,§ mean (SD) 4.8 (3.3) 6.9 (2.8) 5.3 (3.4)

Indication of AIT, no. (%)Allergy to pollen 250 (74.6) 26 (27.7) 276 (64.3)

Allergy to mites 84 (25.1) 67 (71.3) 151 (35.2)

Allergy to both 1 (0.3) 0 (0) 1 (0.2)

Type of AIT, no. (%)

Sublingual 40 (11.9) 8 (8.5) 48 (11.2)

Subcutaneous 294 (87.8) 85 (91.4) 379 (88.6)

Both 1 (0.3) 0 1 (0.2)

AIT regimen, no. (%)

Perennial 314 (93.7) 88 (94.6) 402 (93.9)

Preseasonal/precoseasonal 21 (6.3) 5 (5.4) 26 (6.1)

Other allergic diseases, no. (%)

None 18 (5.4) 20 (21.3) 38 (8.9)

Asthma 36 (10.7) 12 (12.8) 48 (11.2)

Conjunctivitis 123 (36.7) 40 (42.6) 163 (38.0)

Othersk 6 (1.8) 1 (1.1) 7 (1.6)

Symptomatic treatment,{ no. (%)

Oral antihistamines 215 (64.1) 58 (61.7) 273 (63.1)

Topical corticosteroids 199 (59.4) 56 (59.6) 255 (58.9)

Topical antihistamines 95 (28.3) 22 (23.4) 118 (27.3)

Others 43 (12.7) 5 (5.3) 48 (11.2)

ESPRINT-28 questionnaire, overall score,# mean (SD [range]) 1.7 (1.4 [0-5.7]) 2.2 (1.2 [0.1-5.8]) 1.8 (1.3 [0-5.8])

VAS for energy level,** mean (SD [range]) 67.5 (19.3 [0-100]) 61.7 (22.3 [2-100]) 66.3 (20.1 [0-100])

VAS for daily activities,** mean (SD [range]) 74.0 (17.8 [4-100]) 67.0 (21.5 [6-100]) 72.5 (18.8 [4-100])

VAS for overall quality of life,** mean (SD [range]) 74.0 (18.7 [2-100]) 67.2 (19.2 [25-100]) 72.5 (19.0 [2-100])

*AR is defined as intermittent when the patient has symptoms 4 days or less per week or for 4 consecutive weeks or less.

�AR is defined as persistent when the patient has symptoms more than 4 days per week and for more than 4 consecutive weeks.

�ARIA rhinitis severity modifyed by Valero28 is defined as mild (0 items), moderate (1-3 items), or severe (4 items).

§The assessment of the severity of symptoms was conducted by marking the 4 items of the TSS4, each scored from 0 to 3 (0, no symptoms; 1, mild symptoms; 2, moderate

symptoms; and 3, severe symptoms).

kOf the patients who indicated ‘‘other’’ allergic history, these consisted mainly of dermatitis, hives, and food allergies.

{Multiple-choice question in which a patient can indicate more than 1 answer.

#Questionnaire with 7 response options of 0 (‘‘Not bothered me at all’’) to 6 (‘‘I was bothered a lot’’) and a total score range (excluding the independent item general health) of 0 to

5.92 (low effect of rhinitis on quality of life related to health 4 high effect of rhinitis on quality of life related to health).

**VASs in the upper and lower ends in which the fixed values range from 0 to 100, respectively, describing the absence or presence of the attribute maximum being evaluated.

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JUSTICIA ET AL 1541

satisfaction with AIT according to variables such as the level of patient

satisfaction with respect to external criteria (study group), months receiving

AIT, type and severity of AR, and presence and severity of AR symptoms, such

as rhinorrhea, nasal itching, obstruction, and sneezing, as well as the use of

drug treatment forAR.The convergent-discriminant validitywas also tested by

estimating Spearman correlation coefficients between the ESPIA question-

naire and the scores of the ESPRINT-28; VASs concerning satisfaction with

AIT, energy, activities of daily living, and overall quality of life; and the TSS4.

Sensitivity to change was assessed by calculating the effect size (ie, the

standardized mean score change) and the standardized response mean in the

subgroup of patients who reported at least a ‘‘small improvement’’ in the health

status transition item (therewere not sufficient patients to analyze sensitivity to

deterioration) on the aforementioned item. Effect size values of approximately

0.2 were considered to represent a small change, whereas values of approx-

imately 0.5 indicated a moderate change and values of approximately 0.8 or

higher represented a great change in the attribute of interest.27 The standard-

ized response mean was calculated by dividing the mean change in score by

the SD of the change scores between the 2 study visits.26

Statistical analyses were carried out with SPSS software (SPSS Institute,

Cary, NC).

TABLE II. Feasibility, score distributions, and reliability of the ESPIA questionnaire (n 5 429)

Variable Global score

Perceived

efficacy

Activities and

environment Cost-benefit balance

Overall

satisfaction

Items, no. 16 4 6 3 3

Mean (observed range) 64.5 (0-100) 60.9 (0-100) 61 (0-100) 66.8 (0-100) 73 (0-100)

SD 24.5 25.4 26.4 28.7 26.3

Observed range* 0-100 0-100 0-100 0-100 0-100

Floor,� no. (%) 4 (0.9) 8 (1.9) 14 (3.3) 19 (4.4) 10 (2.3)

Ceiling,� no. (%) 5 (1.2) 24 (5.6) 25 (5.8) 90 (21) 101 (23.5)

Internal consistency, Cronbach a 0.90 0.859 0.920 0.908 0.894

Test-retest reliability among stable patients (n 5 65)

Mean (SD) score at baseline visit 43.7 (22.5) 39.2 (22.7) 42.1 (21.9) 45.4 (29.8) 49.5 (27.9)

Mean (SD) score at retest visit 43.8 (21.8) 39.6 (22.3) 43.4 (22.4) 42.8 (27.1) 49.9 (25.7)

Intraclass correlation coefficient 0.919 0.892 0.806 0.850 0.917

*Overall score ranges from 0 (low satisfaction) to 100 (high satisfaction).

�Percentage of patients with the worst possible score.

�Percentage of patients with the best possible score.

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1542 JUSTICIA ET AL

RESULTSThe study population consisted of 429 patients: 335 in group

A and 94 in group B. The overall patient profile was a youngperson with persistent moderate-to-severe AR who followedsymptomatic treatment with oral antihistamines, topical cortico-steroids, or both. All patients were undergoing AIT, mainlythrough the subcutaneous route (Table I28).In terms of feasibility, 362 (84.4%) patients considered that

the ESPIA questionnaire was easy or very easy to answer, andthe mean time required for its administration was less than 7minutes (mean, 6.7; SD, 4.9). More than 94% of the studypatients (n 5 404) answered 100% of the questionnaire items.In general, all of the items showed low levels of missinganswers (<1%). Floor/ceiling effects were low (<6%) for theoverall and dimension scores, with the exception of ceilingeffect for the cost-benefit balance and overall satisfactiondimensions (21% and 23.5%, respectively). The Cronbach avalue for the overall score was 0.90 and was at least 0.86 foreach dimension. The intraclass correlation coefficient valuesfound in the subgroup of patients whose disease was consideredstable were greater than 0.81 for the dimensions and 0.92 for theoverall score (Table II).

After studying the construct questionnaire validity, it wasobserved that group B patients presented a significantly lower(worse) score than those of group A with respect to the ESPIAquestionnaire, both in the overall score and in the 4 dimensions ofthe questionnaire (P < .001). On the other hand, all the new ques-tionnaire’s scores improved the longer the specific immunother-apy treatment lasted (P < .001). Moreover, the persistent ARtype, severe intensity of the same, presence of conjunctivitis,greater severity of AR symptoms (rhinorrhea, nasal itching, ob-struction, and sneezing), and use of medication for AR was asso-ciated with a lower score (worse) in the ESPIA questionnaire bothin the overall score and the 4 dimensions of the questionnaire(P 5 .042 to P < .001, Table III).As seen in Table IV, there is good association between the

overall score and the dimensions of the ESPIA questionnaire,self-perceived health status (in terms of both general healthand the severity of the allergy symptoms experienced), self-perceived effect of the allergy on the patient’s life, and his orher expectations regarding the vaccine. In this way, when generalhealth status is better, there is a lower severity of allergy symp-toms, a lesser effect of the same on the patient’s life, and greater

expectations with respect to the vaccine, and the overall and di-mension scores obtained in the ESPIA questionnaire are greater(better), all of which present a gradual, consistent, and statisti-cally significant increase (P < .001).The comparison of ESPIA scores with other health measures

(eg, ESPRINT-28, VAS-satisfaction, VAS-energy, VAS–activitiesof daily living, VAS–overall quality of life, and TSS4)revealed stronger correlations between ESPIA scores and VAS-satisfaction (overall 5 0.85; dimensions 5 0.73-0.79) thanbetween ESPIA scores and ESPRINT overall scores (overall 50.53; dimensions5 0.40-0.53); between ESPIA scores and VASsof energy, activities of daily living, and quality of life (overall 50.38-0.45; dimensions 5 0.27-0.45); and between ESPIA scoresand symptom severity (overall 5 0.45; dimensions 5 0.14-0.47;Fig 1).

Sensitivity to change (Table V) was assessed among the sub-group of 80 patients who self-reported an improvement in theirhealth status since the time of their initial visit 4 months earlier.In this sense, and consistent with the aforementioned, the effectsize for all ESPIA scores also indicated greater health improve-ment (0.7-1.1).

DISCUSSIONThe validation study of the ESPIA questionnaire is the last

phase of a project with the aim of developing and validating thefirst questionnaire to measure the satisfaction of patients withrespiratory allergies who receive AIT. Such an instrument couldpossibly represent a valuable addition to other outcome measuresused in immunotherapy research (ie, compliance to years ofimmunotherapy is critical) because the assessment of patientsatisfaction could identify the strengths and weaknesses of certainaspects of the immunotherapy treatment.The included sample has been sufficiently heterogeneous from

both a sociodemographic and clinical point of view to reflect thevariability of the main characteristics of the allergic patient inSpain. This heterogeneity within the studied sample providesexternal validity to the outcomes. There are 2 aspects that, underthe criteria of the investigating group, could deviate from thecurrent reality of this patient. On the one hand there is the level ofeducation received (82% of the included sample had an educationlevel of medium/high to high, whereas in the AIT population thispercentage would be presumably lower),29 and on the other hand

TABLE III. Mean (SD) scores for the ESPIA questionnaire overall and dimension scores,* according to clinical baseline

characteristics (n 5 429)

Variable Global score Perceived efficacy Activities and environment Cost-benefit balance Overall satisfaction

Group of patients

Group A 69.8 (22.0) 66.6 (23.0) 65.9 (24.8) 71.5 (26.3) 78.7 (22.7)

Group B 45.4 (23.7) 40.9 (23.4) 43.5 (24.7) 49.6 (30.6) 52.8 (28.5)

P value <.001 <.001 <.001 <.001 <.001

Months receiving AIT�<6 mo� 44.2 (21.1) 40.8 (21.9) 42.7 (22.6) 46.8 (30.0) 52.2 (26.4)

6-12 mo 61.5 (23.4) 60.8 (23.4) 57.5 (26.2) 62.7 (27.1) 71.1 (25.4)

13-24 mo 69.1 (22.9) 64.6 (25.2) 66.4 (24.9) 71.1 (26.7) 76.1 (22.9)

25-36 mo 71.8 (20.4) 68.0 (21.4) 67.5 (22.5) 73.5 (25.3) 81.6 (21.1)

36 mo 73.6 (21.6) 70.0 (21.7) 68.5 (25.6) 76.6 (25.7) 83.3 (22.6)

Spearman rho 0.39 0.344 0.337 0.318 0.393

P value§ <.001 <.001 <.001 <.001 <.001

Type of AR

Intermittent 68.6 (23.8) 64.7 (25.2) 64.4 (24.7) 72.9 (27.0) 76.8 (25.5)

Persistent 61.0 (24.7) 57.5 (25.2) 58.2 (27.6) 61.5 (29.1) 69.9 (26.6)

P valuek .001 .002 .033 <.001 .002

Intensity of AR

Mild 78.4 (20.3) 74.0 (23.2) 73.4 (23.3) 83.6 (23.7) 87.4 (18.6)

Moderate 63.3 (23.7) 59.7 (24.8) 60.1 (25.6) 64.5 (27.5) 71.6 (26.1)

Severe 58.4 (25.9) 53.9 (25.3) 54.9 (27.9) 61.4 (31.2) 66.0 (28.4)

P value§ <.001 <.001 <.001 <.001 <.001

Presence of conjunctivitis

No 72.4 (23.6) 69.2 (24.6) 66.6 (26.8) 76.1 (27.5) 81.0 (22.1)

Yes 65.5 (23.1) 61.7 (23.8) 62.1 (25.3) 67.6 (26.8) 74.0 (25.1)

P valuek .011 .012 .083 .008 .026

Intensity of rhinorrhea

Absence 78.9 (19.3) 76.9 (20.6) 73.6 (22.2) 83.2 (22.5) 86.5 (19.1)

Mild symptoms 67.3 (22.8) 63.9 (23.8) 63.3 (25.9) 68.3 (27.5) 77.2 (23.5)

Moderate symptoms 55.7 (23.0) 51.6 (24.0) 53.7 (24.7) 58.0 (26.6) 63.4 (26.4)

Continuous severe symptoms 50.7 (27.1) 45.7 (23.4) 48.5 (29.2) 52.0 (33.3) 58.5 (31.3)

P value§ <.001 <.001 <.001 <.001 <.001

Intensity of nasal itching

Absence 75.6 (21.1) 73.2 (21.9) 71.0 (24.1) 77.3 (25.1) 83.3 (20.2)

Mild symptoms 68.0 (23.3) 64.6 (24.8) 64.3 (25.3) 69.4 (28.1) 76.9 (25.3)

Moderate symptoms 57.9 (23.0) 52.8 (23.8) 54.7 (25.6) 62.0 (27.3) 66.6 (25.8)

Continuous severe symptoms 49.3 (27.2) 46.6 (24.7) 47.1 (27.7) 49.3 (32.4) 56.9 (31.5)

P value§ <.001 <.001 <.001 <.001 <.001

Intensity of nasal obstruction

Absence 78.4 (17.8) 75.1 (20.3) 74.8 (20.9) 80.9 (21.9) 84.7 (18.7)

Mild symptoms 67.0 (21.9) 64.3 (22.1) 62.6 (23.8) 69.3 (26.4) 77.2 (24.0)

Moderate symptoms 57.0 (24.5) 52.8 (25.2) 54.7 (27.0) 58.3 (28.9) 65.4 (27.0)

Continuous severe symptoms 50.9 (26.3) 46.3 (25.8) 46.9 (27.4) 53.6 (31.5) 60.0 (29.9)

P value§ <.001 <.001 <.001 <.001 <.001

Intensity of sneezing

Absence 76.7 (20.3) 75.3 (19.9) 72.8 (23.4) 78.4 (25.3) 84.6 (19.9)

Mild symptoms 67.1 (22.9) 63.6 (24.1) 63.2 (25.3) 70.1 (26.5) 77.0 (23.3)

Moderate symptoms 60.3 (23.6) 54.4 (24.6) 57.1 (25.9) 63.1 (28.2) 67.2 (27.4)

Continuous severe symptoms 46.8 (25.7) 44.2 (24.8) 44.5 (26.4) 46.5 (30.3) 54.8 (30.1)

P value§ <.001 <.001 <.001 <.001 <.001

Use of drug treatment for AR

No 71.0 (22.6) 72.2 (20.9) 65.2 (27.2) 72.2 (26.7) 81.4 (20.5)

Yes 63.8 (24.7) 59.6 (25.6) 60.6 (26.3) 66.2 (28.9) 72.0 (26.8)

P valuek .063 .002 .242 .168 .042

P values in boldface indicate statistical significance.

*Overall score ranges from 0 (low satisfaction) to 100 (high satisfaction).

�Months receiving specific immunotherapy in patients with perennial specific immunotherapy, entire sample (n 5 402).

�This layer exclusively includes patients in group B with perennial specific immunotherapy who have this information; all other layers include only patients in group A.

§P values calculated by using the nonparametric Kruskal-Wallis test, with a 2-sided 95% CI.

kP values calculated by using the nonparametric Mann-Whitney test, with a 2-sided 95% CI.

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there is the fact that group A consisted predominantly of patientswith pollen allergy (74.6%), whereas group B consisted of pa-tients with mite allergy (71.3%). This last aspect was probably

due to the fact that group A data gathering was to be performedonly once and the study patient’s inclusion period coincided, inpart, with the pollination period of trees and grasses in Spain,

TABLE IV. Mean (SD) scores for the ESPIA questionnaire overall and dimensions scores,* according to patient-perceived health

status (n 5 429)

Variable Global score

Perceived

efficacy

Activities and

environment

Cost-benefit

balance

Overall

satisfaction

How would you describe your health?

Excellent 80.8 (22.7) 82.3 (21.8) 77.6 (26.3) 80.2 (24.8) 85.8 (21.8)

Very good 74.5 (20.8) 71.5 (22.2) 70.5 (23.9) 76.7 (24.9) 84.4 (20.3)

Good 63.6 (22.0) 59.3 (22.9) 60.0 (24.8) 66.9 (26.8) 73.5 (23.3)

Regular 43.4 (23.6) 40.3 (23.0) 41.6 (23.4) 45.3 (29.8) 49.6 (28.1)

Bad 49.2 (26.7) 41.3 (20.1) 61.5 (32.7) 45.0 (26.1) 46.7 (24.0)

Very bad 17.2 (—) 21.9 (13.3) 22.9 (2.9) 16.7 (—) 16.7 (11.8)

P value� <.001 <.001 <.001 <.001 <.001

How intense are your current allergy symptoms?

No symptoms 75.9 (24.5) 74.6 (26.0) 72.5 (26.9) 75.3 (26.9) 83.0 (21.5)

Mild 76.6 (18.2) 73.6 (19.1) 72.8 (21.5) 78.5 (21.7) 85.0 (18.3)

Moderate 59.6 (21.0) 54.6 (22.2) 56.3 (23.5) 62.2 (26.8) 68.9 (23.9)

Pretty severe 45.2 (27.1) 42.1 (26.2) 41.9 (27.7) 47.8 (33.6) 52.7 (31.3)

Extremely severe 42.2 (41.4) 36.3 (38.6) 40.3 (33.6) 50.0 (44.7) 45.8 (43.7)

P value� <.001 <.001 <.001 <.001 <.001

How would you rate the effect of allergies on your life right now?

No effect 78.3 (20.0) 77.4 (22.6) 74.7 (24.2) 77.9 (23.3) 87.3 (17.5)

Slight effect 75.1 (18.5) 71.6 (19.8) 71.7 (21.5) 76.6 (23.3) 82.8 (20.1)

Moderate effect 56.1 (22.5) 51.8 (23.0) 52.5 (24.8) 59.2 (27.6) 65.7 (25.0)

Strong effect 48.9 (28.6) 44.3 (26.1) 44.8 (27.2) 52.4 (35.7) 56.6 (32.3)

Very strong effect 39.1 (33.4) 34.4 (35.4) 38.3 (30.5) 41.7 (41.0) 44.2 (42.0)

P value� <.001 <.001 <.001 <.001 <.001

What do you expect from your vaccine for allergy?

I expect a lot 70.3 (23.1) 65.9 (25.0) 66.1 (25.3) 73.8 (26.3) 79.2 (23.9)

I expect quite a lot 64.8 (21.5) 61.7 (22.6) 61.2 (24.2) 66.6 (26.3) 73.5 (23.2)

I expect between little and quite a lot 38.1 (21.7) 33.3 (18.8) 37.0 (24.1) 36.3 (26.2) 45.5 (26.8)

I expect little 27.0 (34.6) 29.5 (29.9) 23.8 (34.8) 27.4 (40.5) 29.8 (36.9)

I do not expect anything 8.6 (12.2) 6.3 (8.8) 12.5 (17.7) 8.3 (11.8) 4.2 (5.9)

P value� <.001 <.001 <.001 <.001 <.001

P values in boldface indicate statistical significance.

*Overall score ranges from 0 (low satisfaction) to 100 (high satisfaction).

�P values calculated by using the nonparametric Kruskal-Wallis test, with a 2-sided 95% CI.

FIG 1. Spearman correlation between the ESPIA questionnaire scores and the other patient-centered health

outcomes measures of the study. AE, Activities and environment dimension score; COB, cost-benefit bal-

ance dimension score; GS, ESPIA overall score; OS, overall satisfaction dimension score; PE, perceived ef-

ficacy dimension score.

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1544 JUSTICIA ET AL

which favored the inclusion of patients with pollen allergies re-ceiving AIT and in group B the inclusion of patients with AITwith mite allergy, albeit dissatisfied (a requisite to take part in

this study group), because they presented perennial symptomsthat made it more conducive for them to belong to this group un-dergoing longitudinal follow-up. In both groups there exist a high

TABLE V. Sensitivity to change and clinical significance of the improvement in ESPIA questionnaire scores (n 5 80)

Variable Global score Perceived efficacy Activities and environment Cost-benefit balance Overall satisfaction

Baseline visit

Mean (SD) 47.3 (22.4) 42.9 (22.5) 45.4 (23.3) 51.2 (30.3) 54.5 (28.0)

95% CI 42.1-52.5 37.9-47.9 40.1-50.7 44.3-58.1 48.2-60.8

Visit at 4 mo

Mean (SD) 69.7 (18.5) 67.2 (18.2) 66.2 (20.5) 73 (24.9) 75.9 (19.91)

95% CI 65.2-74.2 63-71.4 61.6-70.8 67.4-78.6 71.4-80.4

P value* <.001 <.001 <.001 <.001 <.001

Effect size 1.0 1.1 0.9 0.7 0.8

Standardized response mean 1.1 1.2 1 0.9 0.8

*P values calculated by using the nonparametric Wilcoxon test for paired samples, with a 2-sided 95% CIs.

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number of polysensitized patients, and moreover, the analyzedpopulation is sufficiently large and suitable for the analysis per-formed in terms of both proportions and absolute values (the num-ber of cases is always approximately >_30 cases).The ESPIA questionnaire has obtained satisfactory outcomes

in terms of feasibility and acceptance by the target patient. In thissense the questionnaire is quick to administer (6-7 minutes)without age or level of education having any influence on it (datanot shown), and the questionnaire is perceived as being quite orvery easy to answer (74.3%), especially among persons with ahigher level of education (data not shown). The volume ofmissinginformation (assessed through the average number of missingresponses and the number of complete responses to the question-naire) is minimal.After assessing the floor-ceiling effects, both for the overall and

dimension scores, it can be said that the score range of the ESPIAquestionnaire adequately covers the concept of satisfaction withspecific immunotherapy because the presence of both effects issatisfactory. However, there really is a relevant ceiling effectpresence (>20%; patients with the highest possible score, which isto say, with the greatest possible satisfaction assessed bymeans ofthe questionnaire) in 2 dimensions of the questionnaire. In theory,this would make it impossible to detect higher degrees ofsatisfaction than those reflected by said scores, but this limitationhas a much smaller practical effect in terms of the potential use ofthis measure.In terms of internal consistency, the ESPIA questionnaire

obtains satisfactory reliability outcomes, both overall and dimen-sionally, so that all the estimated Cronbach a values comfortablyexceed the 0.70 threshold (minimum recommended value) andmost reach a 0.90 threshold (the value that some authors considernecessary for individualized use of a measure).25,30

In terms of test-retest reliability, the ESPIA questionnaire hasshown itself to be stable when measured conditions do notchange. In this case the test-retest reliability has been assessed in asubgroup of 65 patients whose health status with respect to theallergy is kept stable at 7 to 10 days after their inclusion in thestudy. The intraclass correlation coefficient obtained overall anddimensionally was in all cases greater than 0.70 (the minimumrecommended value)26 within a parameter, with the proximity to1 showing high stability.The ESPIA questionnaire presents satisfactory results in

terms of validity. On the one hand, their scores are moreclosely associated with instruments and/or items approachingthe assessed concept, as would be satisfaction with specificimmunotherapy measured by way of VASs than with instru-ments more distanced from said concept, such as energy level,

the ability to perform daily activities, quality of life, or theseverity of AR symptoms. This pattern is shown both in theoverall score of the scale and the scores corresponding to theirdimensions. On the other hand, when comparing the ESPIAquestionnaire scores between different patient groups accordingto certain baseline clinical characteristics, the ESPIA scoresbehave consistently with those expected scores, so that patientswith less baseline satisfaction with respect to external criteria(group B vs group A), patients who have been receiving specificimmunotherapy for a shorter period of time, patients withpersistent AR types, and patients presenting with greaterseverity of AR symptoms have lower scores in the ESPIAQuestionnaires (ie, they present worse satisfaction with respectto their treatment with AIT). Lastly, the ESPIA questionnairescores are also consistently associated with the patient’s self-perceived health status and with their expectations regarding thevaccine, so that the better health status is and the greater theexpectations are with AIT, the better are the scores obtainedwith the ESPIA questionnaire.Finally, the ESPIA questionnaire’s analysis of sensitivity to

change also produces satisfactory outcomes in that the ques-tionnaire’s scores change consistently over time when theconcept measured also changes. The changes detected by thequestionnaire were of great magnitude (Cohen effect sizeparameter is around >_0.8), which proves the questionnaire’sability to obtain different and consistent scores with regard tothe measuring conditions of the measured concept. However, onthis occasion, it has not been possible to test the questionnaire’ssensitivity when the patient’s satisfaction with regard to AITworsens, so that there is no evidence that the questionnaire isalso able to detect said changes. On the other hand andalthough the sample being used in this analysis consists, inthe main, of patients with mite-related AIT (71.3%), we believethat the results could be valid for the general population ofpatients with allergy in the case that satisfaction with thevaccine would not differ relevantly whether the patient wasvaccinated against pollen or mites. However, there are currentlyno data in this regard.The outcomes of the current study make it possible to state that

the ESPIA questionnaire presents some satisfactory psychometricproperties in terms of viability, reliability, validity, and sensitivityto change, which makes it an instrument of potential interest foruse in clinical practice or research. Therefore the current study isthe fulfillment of a project with the aim of providing the scientificcommunity and allergologists with a standardized and systematicinstrument that is able to adequately assess the allergic patient’ssatisfaction with AIT treatment.

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1546 JUSTICIA ET AL

Clinical implications: Assessment of satisfaction (and its conse-quent repercussions in terms of adherence and effectiveness) isa key factor in long-term treatments, such as AIT.

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TABLE E1. Spanish original version of the patient satisfaction with allergen-specific immunotherapy scale: ‘‘Valore las siguientes

situaciones, pensando en su vacuna para la alergia. En los �ultimos 2 meses, ¿con qu�e qu�e frecuencia ha estado de acuerdo con

estas frases?’’

Siempre

Muchas

veces

La mitad del

tiempo

De vez en

cuando Nunca

1. Desde que me vacuno para la alergia, tengo menos s�ıntomas. 5 4 3 2 1

2. Mi vacuna funciona. 5 4 3 2 1

3. Gracias a la vacuna estoy menos pendiente de llevar encima otros f�armacos (pastillas,

inhaladores, etc).

5 4 3 2 1

4. Mi vacuna funciona m�as r�apido de lo que esperaba. 5 4 3 2 1

5. Gracias a la vacuna ya no evito cosas ni lugares que antes me causaban alergia. 5 4 3 2 1

6. Mi vacuna me ayuda a realizar mis actividades diarias. 5 4 3 2 1

7. Desde que me vacuno puedo ir a cualquier sitio con mi familia o amigos. 5 4 3 2 1

8. Gracias a la vacuna puedo trabajar o estudiar mejor. 5 4 3 2 1

9. Desde que me vacuno disfruto m�as de las actividades al aire libre. 5 4 3 2 1

10. Desde que me vacuno no me encuentro en situaciones inc�omodas o comprometidas

causadas por la alergia.

5 4 3 2 1

11. Desde que me vacuno he ganado calidad de vida. 5 4 3 2 1

12. El buen funcionamiento de la vacuna me compensa todas las gestiones que tengo que

hacer para conseguirla (visitas, recetas, permisos, etc).

5 4 3 2 1

13. El buen funcionamiento de la vacuna compensa el esfuerzo econ�omico que me supone. 5 4 3 2 1

14. El buen funcionamiento de la vacuna compensa las molestias que pueda ocasionarme. 5 4 3 2 1

15. En general, estoy satisfecho con mi vacuna para la alergia. 5 4 3 2 1

16. En general, recomendar�ıa el tratamiento con vacuna a otras personas. 5 4 3 2 1

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TABLE E2. English version of the patient satisfaction with allergen-specific immunotherapy scale*: ‘‘Assess the following

situations, thinking about your allergy vaccine. During the last 2 months, how often have you agreed with these sentences?’’

Always Many times

Half of

the time At times Never

1. Since being vaccinated for my allergy, I have fewer symptoms. 5 4 3 2 1

2. My vaccine works. 5 4 3 2 1

3. Thanks to the vaccine, I am less dependent on carrying other medication (pills, inhalers, etc). 5 4 3 2 1

4. My vaccine works faster than I expected. 5 4 3 2 1

5. Thanks to the vaccine, I no longer avoid things or places that caused my allergy. 5 4 3 2 1

6. My vaccine helps me to perform my daily activities. 5 4 3 2 1

7. Since being vaccinated, I can go anywhere with my family and friends. 5 4 3 2 1

8. Thanks to the vaccine, I can work or study better. 5 4 3 2 1

9. Since being vaccinated, I enjoy outdoor activities more. 5 4 3 2 1

10. Since being vaccinated, I don’t find myself in uncomfortable or compromising situations caused by

my allergy.

5 4 3 2 1

11. Since being vaccinated, I have gained in quality of life. 5 4 3 2 1

12. The good performance of my vaccine compensates for all the things I have to do to get it (visits,

prescriptions, leave, etc).

5 4 3 2 1

13. The good performance of my vaccine compensates for the financial burden it involves. 5 4 3 2 1

14. The good performance of my vaccine compensates for the discomforts it may cause me. 5 4 3 2 1

15. In general, I am satisfied with my allergy vaccine. 5 4 3 2 1

16. In general, I would recommend this vaccine treatment to other people. 5 4 3 2 1

Perceived efficacy dimension: items 1, 2, 3, and 4; daily life activities dimension: items 5, 6, 7, 8, 9, and 10; cost-benefit balance dimension: items 12, 13, and 14; general

satisfaction dimension: items 11, 15, and 16.

*This English-language version has not been subject to the standard process of translation–back translation in accordance with the recommendations of the specialized

bibliography. It is merely a free translation included here for informational purposes only.

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