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nhaled

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Corticosteroid

- Inhaled

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orticosteroid

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Clinical

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Inhaled

(ICQ)

Page 1 of 15

(page number not for citation purposes)

A self-rating scale for patient-perceived side effects of inhaled

corticosteroids

Juliet M Foster*

_{, Eric van Sonderen}

_{, Amanda J Lee}

_{, Robbert Sanderman}

_,

Antoon Dijkstra

_{, Dirkje S Postma}

_{and Thys van der Molen}

Address: 1_{Department of General Practice and Primary Care, University of Aberdeen, UK,} 2_{Department of General Practice, University Medical}

Center Groningen, University of Groningen, The Netherlands, 3_{Northern Center for Healthcare Research, University Medical Center Groningen,}

University of Groningen, The Netherlands and 4_{Department of Pulmonary Diseases, University Medical Center Groningen, University of}

Groningen, The Netherlands

Email: Juliet M Foster* - [email protected]; Eric van Sonderen - [email protected]; Amanda J Lee - [email protected]; Robbert Sanderman - [email protected]; Antoon Dijkstra - [email protected]; Dirkje S Postma - [email protected]; Thys van der Molen - [email protected]

* Corresponding author

Abstract

Background: Patient-reported side effect questionnaires offer a simple method for the systematic

measurement of drug-related side effects. In order to measure patients' inhaled corticosteroids (ICS) related side effect perceptions the 14-day retrospective Inhaled Corticosteroid Questionnaire (ICQ) was developed. In this research we aim to assess the construct validity and reliability of the ICQ and test its responsiveness to dose changes in adult asthma patients.

Methods: In a cross-sectional study, current inhaler users with asthma completed the ICQ (27 with non

ICS inhaler; 61 BDP equivalent daily ICS low dose ≤400 µg; 62 mid dose 401–800 µg; and 105 with high dose >800 µg). We generated 3 construct validity hypotheses: 1) a hierarchical dose-response pattern for scoring of the individual items on the ICQ, and statistically significant differences in the scores of each of the 15 ICQ domains by ICS dose group 2) an association between ICS dose and ICQ scoring after adjusting for appropriate confounders in multiple regression; 3) greater convergence between local side effect domains than between systemic and local domains of the scale. Test-retest reliability was assessed on a randomly selected subgroup of patients (n = 73) who also completed the ICQ a second time after 7 days. In a separate longitudinal study, 61 patients with asthma completed the ICQ at baseline and after changing their daily ICS dose, at 2- and 6- months, in order to test the ICQ's responsiveness.

Results: All three construct validity hypotheses were well supported: 1) a statistically significant difference

existed in scores for 14 domains, the high ICS dose group scoring highest; 2) ICS dose independently predicted ICQ scoring after adjusting for confounders; 3) greater convergence existed between local ICQ domains than between local and systemic domains. The ICQ had good reproducibility: test-retest intraclass correlation coefficients were ≥0.69 for all but the 'Facial Oedema' domain. In the longitudinal study, ICQ scores for 'Voice Problems' changed significantly at 2- and 6-months from baseline and other ICQ domains displayed trends in scoring change accordant with dose modulation at 6-months.

Conclusion: The ICQ has good dose-related discriminative properties, is valid, reliable, and shows

potential responsiveness to ICS dose change.

Published: 24 October 2006

Respiratory Research 2006, 7:131 doi:10.1186/1465-9921-7-131

Received: 20 July 2006 Accepted: 24 October 2006

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Questionnaire (ICQ)

Scoring & administration

The Inhaled Corticosteroid Questionnaire (ICQ) comes in two forms ie. a 57 item questionnaire long form and a 15 item short form. This ICQ is a useful tool for measuring patients' perceptions of ICS associated side effects. The ICQ shows good reliability and validity in asthma patients and has good discriminative properties. Used for systematic measurement, this simple questionnaire may provide a greater understanding of the side effect perceptions of patients in clinical practice and clinical trials, and will yield useful new perspectives on the relationship between perceived side effect of ICS and adherence.

The ICQ covers a range of patient-perceived side effects including voice, throat, skin and mood problems. The ICQ was scored on an item level from 0 (not at all) to 6 (a very great deal) other response options being: 1 (a very little), 2 (a little), 3 (a moderate amount), 4 (quite alot), 5 (a great deal). In order that domain scores with differing numbers of items could be compared, the 15 domain scores were transformed into a score out of 100 The total score of the ICQ (0–100) is the average of the 15 domain scores (sum the scores of 15

domains/15). The highest score represents the greatest side effect.

To calculate a score for a subscale: Add up all the respondents’ answers for each of the questions listed for that subscale (this is the raw score) place it in the subscale equation –

Inhaled Corticosteroid Questionnaire - Long Form (ICQ-LF) Scoring Table -

Subscales

Question Numbers

Subscale Score Range

Voice Problems (VP) 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 21, 22,

23, 24

90 = 100%

% = (𝑉𝑃 𝑟𝑎𝑤 𝑡𝑜𝑡𝑎𝑙

90 ) × 100

Oropharynx Problems (OP) 12, 13, 14, 15, 16, 17, 18, 19, 20 54 = 100%

% = (𝑂𝑃 𝑟𝑎𝑤 𝑡𝑜𝑡𝑎𝑙

54 ) × 100

Unpleasant Taste (UT) 28, 29, 30, 31, 37, 38, 39 42 = 100%

% = (𝑈𝑇 𝑟𝑎𝑤 𝑡𝑜𝑡𝑎𝑙

42 ) × 100

Skin Hair and Nails (SHN) 41, 42, 43, 44, 45, 49, 50 42 = 100%

% = (𝑆𝐻𝑁 𝑟𝑎𝑤 𝑡𝑜𝑡𝑎𝑙

Inhaled Corticosteroid Questionnaire - Short Form (ICQ-SF) Scoring Table -

Subscales

Question Numbers

Subscale Score Range

Voice Problems (VP) 1, 6 = 100%

% = (𝑉𝑃 𝑟𝑎𝑤 𝑡𝑜𝑡𝑎𝑙

6 ) × 100

Oropharynx Problems (OP) 2 6 = 100%

% = (𝑂𝑃 𝑟𝑎𝑤 𝑡𝑜𝑡𝑎𝑙

6 ) × 100

Unpleasant Taste (UT) 5 6 = 100%

% = (𝑈𝑇 𝑟𝑎𝑤 𝑡𝑜𝑡𝑎𝑙

6 ) × 100

Skin Hair and Nails (SHN) 9 6 = 100%

% = (𝑆𝐻𝑁 𝑟𝑎𝑤 𝑡𝑜𝑡𝑎𝑙 6 ) × 100

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instructions

scoring

ICQ

Sample

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Inhaled Corticosteroid

Questionnaire (ICQ-LF)

(ORIGINAL UK ENGLISH VERSION - SEPTEMBER 15, 2003)

©

Patient

Name:__________________________________________________________

Date:___________________________________________________________

How much have you been affected by the following side-effects related to the use of your inhaler/s during the last 14 days?

(Please circle one number on each line)

Not at all A very

little A little A moderate amount Quite a lot A great deal A very great deal

1. Hoarseness of the voice? 0 1 2 3 4 5 6

2. A ‘rough’ voice? 0 1 2 3 4 5 6

3. A noticeable change to your voice? 0 1 2 3 4 5 6

4. Your voice feeling similar to how your voice feels when recovering from the flu?

0 1 2 3 4 5 6 5. Your voice feeling like it had ‘gone to

the back of your throat’? 0 1 2 3 4 5 6

6. Not being able to sing? 0 1 2 3 4 5 6

7. Loss of speech volume so that you

couldn’t talk as loudly as normal? 0 1 2 3 4 5 6

8. A feeling of exhaustion when talking? 0 1 2 3 4 5 6

9. A painful throat when talking? 0 1 2 3 4 5 6

10. A feeling that other people couldn’t understand your speechbecause you speak too softly or not clearly enough?

0 1 2 3 4 5 6

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Inhaled Corticosteroid

Questionnaire

(ICQ-SF)

(ORIGINAL UK ENGLISH VERSION - SEPTEMBER 15, 2003)

Patient ID

During the last 2 weeks how much have you been affected by the following side-effects of your regularly inhaled medication?

(Please circle one number on each line) Not at all A very little A little A moderate amount Quite a lot A great deal A very great deal 1. Hoarseness of the voice?

0 1 2 3 4 5 6

2. A need to clear your throat ? 0 1 2 3 4 5 6

3. An itchy feeling in the back of

your throat. 0 1 2 3 4 5 6

4. Oral thrush (sore throat covered with

pustules, and difficulty swallowing)?

0 1 2 3 4 5 6

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