Control of Allergic Rhinitis and Asthma Test with 1-week recall: Validation of paper and electronic version.

To the Editor,

Both asthma and allergic rhinitis (AR) are high prevalence diseases that frequently occur simultaneously.1, 2 The Allergic Rhinitis and its Impact on Asthma initiative (ARIA) recognizes the need for a concomitant evaluation and treatment of asthma and AR.1, 2 The Control of Allergic Rhinitis and Asthma Test (CARAT)3, 4, 5 measures control of both asthma and AR with a 4‐week recall period. In a time where the use of mobile devices has grown, a new modality to monitor patients is at our disposal. An electronic CARAT questionnaire allows clinicians to gain more insight into the period between visits and therefore could be a convenient and reliable alternative to the use of the current paper version of the CARAT. The main purpose of this study was to investigate the psychometric properties of the CARAT with 1‐week recall period as paper version (CARATp1) and as electronic version (CARATe1).

This is a diagnostic study with repeated measurements in four consecutive weeks. The study population consisted of consecutive Dutch primary care asthma patients who were referred by their general practitioner to the asthma/COPD service.6 Inclusion criteria were as follows: age 18‐80 years and asthma diagnosis (made by a pulmonologist based on lung function tests including reversibility and self‐reported questionnaires). Participation was voluntary, all patients received oral and written information about the study and all patients signed informed consent (study approved by the local medical ethics committee (METc 2014/578)).

In the period between January and August 2015, patients completed the following questionnaires on paper at baseline: CARATp1, ARIA2 questions, Visual Analogue Scale (VAS)7 on airway symptoms, ACQ8 and GINA9 questions. For 4 weeks (T1, T2, T3 and T4), the patients completed the CARATe1 each Monday and the CARATp1 every Tuesday. In the last week, the patients completed also the original CARAT on paper (CARATp4) and an evaluation form (see Table S1, Data S1). The CARAT contains ten questions concerning asthma symptoms (asthma domain) and AR symptoms (AR domain) in the previous 4 weeks and is administered on paper.3, 4, 5 The only difference between the CARATp4 and the CARATp1 was the shorter recall period. The CARATe1 is an electronic application for smart devices developed by AstraZeneca. It shows, after a short instruction screen, the CARAT questions on ten consecutive screens.

The construct validity was calculated using Spearman correlation coefficient (ρ). The CARATp1 at baseline was compared with ARIA, VAS, GINA and ACQ (ρ 0.6‐0.8 was expected).10 The correlation between CARATp1 and CARATe1 was calculated using Spearman correlation coefficient (ρ > 0.80 was expected). The internal consistency of CARATp1 and CARATe1 was determined using Cronbach's alpha (α 0.70‐0.95 was expected).10 The test‐retest reliability of CARATp1 and CARATe1 was evaluated with the intraclass correlation coefficient (ICC > 0.70 was expected).10 Aforementioned analysis was performed with CARAT total scores, CARAT AR domain scores and CARAT asthma domain scores at T1, T2, T3 and T4. The average scores in each week of both CARATp1 and CARATe1 were calculated. Spearman correlations of both CARATp1 and CARATe1 with CARATp4 were calculated (ρ > 0.80 was expected). Statistical analysis was performed using SPSS 25 (IBM, Chicago, USA). Missing data were assumed to be missing at random and replaced using a multiple imputation procedure (see Data S1).

In this study, 123 patients were included for analyses and 23% of the AR patients reported intermitting AR (Table 1) (see Data S1). Construct validity of the CARATp1 was shown by correlation coefficients within the expected range (ρ 0.584‐0.718) with VAS, ACQ, ARIA and GINA. As expected, the highest correlation coefficients were found (a) between AR domain of the CARAT and ARIA and VAS upper airway symptoms; and (b) between the asthma domain of the CARAT and GINA, ACQ and VAS lower airway symptoms (Table 2).

Table 1

Baseline characteristics

Variable	Value	N
Age, mean (SD)	53.2 (14.3)	111
Gender, n (% male)	49 (42.6)	115
Height, mean (SD)	173 (9.8)	115
BMI, mean (SD)	27.7 (5.8)	112
Current/ex‐smokers, n (%)	68 (58.6)	123
Pack years, MED (IQR)a	11 (4.7‐20.0)	62
Allergic rhinitis	52 (51.0)	102
Medication use (total, n)		123
SABA, n (%)	30 (24.4)
LABA, n (%)	63 (51.2)
LAAC, n (%)	12 (9.8)
ICS, n (%)	77 (62.6)
NCS, n (%)	20 (16.3)
Antihistaminic agent, n (%)	12 (9.8)
Other medication, n (%)	11 (8.9)
No medication, n (%)	29 (23.6)
Lung functionb
FEV1, mean (SD)c	93.7 (15.5)	110
FVC, mean (SD)c	105.4 (16.2)	110
FEV1/FVC, mean (SD)	74.0 (8.6)	111
ARIA classification (total, n)		52
Intermitting—mild, n (%)	11 (21.2)
Intermitting—moderate/severe, n (%)	1 (1.9)
Persistent—mild, n (%)	25 (48.1)
Persistent—moderate/severe, n (%)	15 (28.8)
VAS
Airway symptoms, MED (IQR)a	20 (10‐50)	116
Upper airway symptoms, MED (IQR)a	20 (0‐50)	115
Lower airway symptoms, MED (IQR)a	20 (3.125‐50)	116
GINA classification (total, n)		95
Well‐controlled, n (%)	23 (24.2)
Partly controlled, n (%)	42 (44.2)
Uncontrolled, n (%)	30 (31.6)
ACQ classification (total, n)		111
Well‐controlled, n (%)	60 (54.1)
Partly controlled, n (%)	29 (26.1)
Uncontrolled, n (%)	22 (19.8)
CARATp1
Total score, MED (IQR)a	24 (18‐27)	105
AR domain score, MED (IQR)a	8 (6‐11)	112
Asthma domain score, MED (IQR)a	15 (11.5‐17)	109

ACQ, asthma control questionnaire; AR, allergic rhinitis; ARIA, Allergic Rhinitis and its Impact on Asthma initiative; CARAT, Control of Allergic Rhinitis and Asthma Test; FEV1, forced expiratory flow in 1 s; FVC, forced vital capacity; GINA, Global Initiative for Asthma; ICS, inhaled corticosteroid; IQR, interquartile range; LAAC, long‐acting anticholinergic; LABA, long‐acting beta‐agonist; MED, median; NCS, nasal corticosteroid; p1, paper version with 1‐wk recall period; SABA, short‐acting beta‐agonist; SD, standard deviation; VAS, Visual Analogue Scale.

aIQR of pooled data could not be calculated; bPostbronchodilation; cAs percentage of predicted; nonimputed data were used for the descriptive statistics.

Table 2

Spearman correlation in absolute figures as estimation of construct validity of the CARATp1 at baseline

	VAS			GINA	ACQ	ARIA
	Airway symptoms	Upper airway symptoms	Lower airway symptoms
CARATp1 (total)
Correlation	0.602	0.481	0.580	0.555	0.647	0.612
P‐value	<0.001	<0.001	<0.001	<0.001	<0.001	<0.001
CARATp1 (AR)
Correlation	0.347	0.584	0.241	0.166	0.309	0.603
P‐value	<0.001	<0.001	0.007	0.108	0.001	<0.001
CARATp1 (Asthma)
Correlation	0.645	0.257	0.705	0.659	0.718	0.373
P‐value	<0.001	0.004	<0.001	<0.001	<0.001	0.006

All bold printed figures were expected to be >0.60.

ACQ, asthma control questionnaire; AR, allergic rhinitis; ARIA, Allergic Rhinitis and its Impact on Asthma initiative; CARAT, Control of Allergic Rhinitis and Asthma Test; GINA, Global Initiative for Asthma; p1, paper version with 1‐wk recall period; VAS, Visual Analogue Scale.

CARATp1 was highly correlated with CARATe1 (ρ 0.856‐0.923). Internal consistency of both CARATp1 and CARATe1 was good (α 0.754‐0.874) as was the test‐retest reliability (ICC 0.722‐0.931).

CARATp1 and CARATe1 correlated well with the CARATp4 (0.880 and 0.833, respectively). The correlation coefficients of the CARATp4 and the scores in each week of the CARATp1 were 0.680, 0.812, 0.857 and 0.895, respectively. The correlation coefficients of the CARATp4 and the scores in each week of the CARATe1 were 0.643, 0.720, 0.817 and 0.806, respectively.

The majority of patients (93%) considered the electronic version to be easy or very easy to complete and only 6% preferred the paper version (see Figure S1, Data S1).

This study found that the paper and electronic CARAT questionnaires with a 1‐week recall period are valid and reliable, with comparable psychometric properties as the original CARAT4p.3, 4 CARATp1 and CARATe1 were strongly correlated with the original CARAT4p. Also, CARATp1 and CARATe1 were closely correlated. Moreover, the patients participating in this study considered the CARATe1 to be user‐friendly. The clinical relevance of these findings is that both new versions of the CARAT are suitable questionnaires for clinical practice and clinical research in patients with asthma and AR in which the control of both diseases is the outcome of interest.

Interestingly, the correlation of the CARATp4 with the scores in individual weeks of the CARATp1 and the CARATe1 showed increasing correlation coefficients. In both cases, the correlation with the CARATp4 tends to rise as the questionnaires with 1‐week recall are completed closer in time to when the CARATp4 was completed. This may suggest that recent weeks play a more prominent role in the assessment of the patient when completing the CARATp4 than the first weeks in the recall period. One may argue to prefer the CARAT with 1‐week recall period to minimize recall bias.

The CARATe1 was viewed favourably by most patients in this study. Only 6% preferred the CARATp1. This may not be surprising considering the high level of integration in daily life of smart devices. However, one patient considered the CARATe1 to be very hard to complete (65‐year‐old woman). Although this is just one case, it shows that the paper version of the CARAT should not be fully discarded (see Data S1).

Future research should focus on the calculation of the CARAT's cut points to differentiate between controlled and uncontrolled asthma and AR. In addition, the effects of implementation of the CARATe1 on control and management in primary care should be investigated. This study showed that both new versions of the CARAT could be used as convenient tools for both patient and clinician to gain more insight into the control of asthma and AR.

CONFLICTS OF INTEREST

The authors declare that they have no competing interests related to the submitted work. TvdM is currently an employee of GSK.

FUNDING INFORMATION

This work was supported by an unrestricted grant from AstraZeneca (2014). This funding body was not involved in designing the study nor the analysis and interpretation of data and writing the manuscript.

AUTHOR CONTRIBUTIONS

TvdM, IT, JK and BF contributed to conception and design; HB, CdJ, EvH and JdK acquired the data; HB, CdJ, JF, BK and BF analysed and interpreted the data; HB, CdJ, JdK and BF drafted the article; JF, EvH, BK, TvdM, IT and JK revised it critically for important intellectual content; and all authors approved the final version to be published.

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