Personality influences the reporting of side effects of inhaled corticosteroids*
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1 Personality influences the reporting of side effects of inhaled corticosteroids* Dr. Juliet M. Foster Dept. Primary Care University Medical Center Groningen/ University of Aberdeen GRIAC (Groningen( Research Institute for Asthma and COPD) * Accepted for publication in Journal of Asthma
2 Personality influences the reporting of side effects of inhaled corticosteroids How can inhaled corticosteroids cause side effects and why are side effects important? The ICQ: a patient-reported ICS-specific side effect questionnaire The influence of personality on the reporting of side effects
3 Personality influences the reporting of side effects of inhaled corticosteroids How can inhaled corticosteroids cause side effects and why are side effects important? The ICQ: a patient-reported ICS-specific side effect questionnaire The influence of personality on the reporting of side effects
4 ICS side effects and their importance Inhaled corticosteroids (ICS) currently the most effective medications for control of underlying airway inflammation of asthma Modern prescribing: Earlier in the course of therapy For longer periods Often at high doses This has led to concerns about the potential for ICS-related side effects NIH Publication No ; Hanania N.A, et al. Am J Med. 1994;98: ; Wasserfallen J, et al. J Allergy Clin Immunol. 1996;97: ; Toogood JH. J Allergy Clin Immunol. 1998;102:
5 How can inhaled corticosteroids cause side effects? 10-50% ICS deposited in the lungs Absorption from the lungs Mouth and Oropharynx Lungs Systemic circulation 50-90% ICS swallowed Local side effects Absorption from gut Orally available fraction Liver Systemic side effects GI tract First pass inactivation Almost all cells in the body have corticosteroids receptors!
6 Local side effects: hoarseness cough thirst Typical side effects of ICS dysphonia oral thrush Toogood JH. J Allergy Clin Immunol. 1998;102: Williamson IJ, et al. Eur Respir J. 1995;8: Shim C, Williams MH. Chest. 1987;91: Capewell S, et al. Br Med J. 1990;300: Mak VHF, et al. Eur Respir J. 1992;5: Cumming RG, et al. N Engl J Med. 1997;337:8-14. Jick SS, et al. Epidemiology. 2001;12: Mitchell P, et al. Ophthalmology. 1999;106: Connett G, Lenney W. Lancet. 1991;338: Systemic side effects: bruising / thinning of skin bone mineral density loss growth reduction glaucoma / cataract behavioral changes: insomnia listlessness hypothalamic-pituitary pituitary-adrenal adrenal (HPA) axis suppression
7 ICS side effects and their importance Cross-sectional sectional GAPP survey in 16 countries (Africa, Asia, Europe, N. & S. America) 1726 asthma patients (aged 18 years) surveyed Have any of the [ICS] side effects you have experienced since being diagnosed caused you to? Incidence reported % Change dosage Skip doses Stop taking medications Canonica, G.W. et al. Proc.Am.Thor. Soc. 2006; 3:1982 [Abstract]
![America) 1726 asthma patients (aged 18 years) surveyed Have any of the [ICS] side effects you have](/docs-images/50/15658851/images/page_7.jpg "experienced since being diagnosed caused you to?")
8 ICS side effects and their importance Retrospective analysis of ICS refills in Michigan USA A total of 405 asthma patients aged years, 176 had collected 1 1 ICS prescription , 2001, allowing adherence to be calculated % patients adherent to prescribed ICS regimen estimated by medication refill rates (CMG*) % of patients non-adherent Each 25% increase in time without ICS was associated with ~double the rate of asthma- related hospitalizations (RR 1.80; 95% CI ) 20 0 Adherence Williams et al. J.Allergy Clin.Immunol. 2004; 114: *Continuous medication gaps (CMG) = total days of treatment gaps/total no. days between ICS refills
9 Personality influences the reporting of side effects of inhaled corticosteroids How can inhaled corticosteroids cause side effects and why are side effects important? The ICQ: a patient-reported ICS-specific side effect questionnaire The influence of personality on the reporting of side effects
10 The Inhaled I Corticosteroids Questionnaire: a patient-reported ICS-specific side effect questionnaire Dental decline Dry eyes Swollen face Grumpy Mood swings Easily irritated Oral thrush Itchy feeling on roof of mouth Itchy feeling back of throat Coughing up phlegm Coughing Coughing up thick mucus Thick mucus coming up Need to clear throat Thick mucus sticks at back of throat Mucus in your throat Clump in throat Feeling layer of mucus stays on back of throat Sweating Night Sweating Dry skin Dry skin on face Bruising easily Long period painful bruising Thin or less flexible skin Brittle breaking nails Hair loss Change in taste ability Loss of taste Loss of appetite Feeling thirsty Wanting to drink liquid Tiredness Difficulty sleeping Taste on teeth Terrible taste in mouth Bad taste in mouth Bad breath Wanting to rinse mouth Wanting to brush teeth Wanting to chew gum Vision deterioration Voice gone to back of throat Rough voice Noticeable change to voice Recovering from flu voice Hoarseness Unable to sing Loss of speech volume Feeling of exhaustion when talking Painful throat when talking Feeling people can t understand your speech Breaking voice Rough throat Sore throat Unpleasant feeling in throat Dry throat 57 Questions:
11 Inhaled Corticosteroids Questionnaire Validity: Dose-response reporting % patients scoring >0 on the ICQ Non ICS Low dose ICS Mid dose ICS High dose ICS % patients scoring >0 on the ICQ Hoarseness of the voice 2. A 'rough' voice 3. A noticeable change to your voice 4. [Your voice similar to recovering from flu] 5. [Your voice 'gone to back of throat'] 6. Not being able to sing 7. [Loss of speech volume] 8. A feeling of exhaustion when talking 9. A painful 10. [Others throat when can't talking understand 80 your speech] 11. A breaking voice 21. A 'rough' throat 22. A sore throat 23. An unpleasant feeling in your throat 24. A dry throat Feeling 'grumpy' 47. Mood swings 48. Feeling 'easily irritated' Items in Mood Problems domain of the ICQ Items in Voice Problems domain of the ICQ 70 % patients scoring >0 on the ICQ Foster JM, et al. Respir Res. 2006;7: Dry skin 42. Dry skin 43. Bruising 44. [Bruises on the face easily painful for a long period] 45. [Thinner or less flexibility in your skin] Items in Skin, Hair an d N ails d om ain o f the IC Q 49. Brittle nails, or your nails breaking easily 50. Hair loss
![[Your voice 'gone to back of throat'] 6. Not being able to sing 7. [Loss of speech volume] 8. A feeling of exhaustion when talking 9. A painful 10.](/docs-images/50/15658851/images/page_11.jpg "[Others throat when can't talking understand 80 your speech] 11. A breaking voice 21. A 'rough' throat 22. A sore throat 23. An unpleasant feeling in your throat 24. A dry throat 10 0 46.")
12 Personality influences the reporting of side effects of inhaled corticosteroids How can inhaled corticosteroids cause side effects and why are side effects important? The ICQ: a patient-reported ICS-specific side effect questionnaire The influence of personality on the reporting of side effects
13 Background Negative affect is a general dimension of subjective distress and unpleasurable engagement that includes aversive mood states such as anger, contempt, disgust, guilt, fear and nervousness 1 Negative affectivity (NA) corresponds to the dominant personality factors of anxiety/neuroticism Increased NA is associated with increased reporting of symptoms (of up to 3 times higher) or general health complaints 2,3 Few studies have investigated the relationship between NA and medication-induced induced symptoms 1. Watson D, et al. Psych Bull 1984; 96(3): Watson D. et al. J Person Soc Psych 1988; 54(6): ; 3. Costa PT, et al. Am Psych 1985; 40(1):19-28.
14 Design and Aim A cross-sectional sectional survey of patients using inhaled corticosteroids (ICS) for asthma treatment Utilising the validated ICS-specific side effect scale the ICQ 1-4 We examine the relationship between side effect- reporting and negative affectivity in asthma patients using ICS We also investigate the influence of daily ICS dose 1. Mear I et al. Qual Life Res 2007; A-86: 1404; 2. Foster JM et al. Resp Res 2006; 7:131; 3. Foster JM, et al. Respir Med 2006; 100(8): ; 4. van der Molen T et al. Value in Health 2006; 9(6):A336.
15 Participants Asthma patients taking ICS (aged 16 to 74 years; 20 pack years; with a physician-diagnosis of asthma) No oral corticosteroids (previous 4 weeks), corticosteroid injections (previous 6 months) or change in ICS dose (previous 14 days)
16 Methods Patients consented to complete a self-report questionnaire including: Side effects: : Inhaled Corticosteroid Questionnaire (ICQ); 57- items; scored: 0 (best) (worst)) Negative affectivity: : Positive and Negative Affect Schedule (PANAS) scored 10 (lowest) - 50 (highest)
17 Positive and negative affectivity schedule NA NA NA NA NA NA Low NA: Average NA NA NA High NA >2.5 NA NA
18 Methods Patients consented to complete a self-report questionnaire including: Side effects: : Inhaled Corticosteroid Questionnaire (ICQ); 57- items; scored: 0 (best) (worst)) Negative affectivity: : Positive and Negative Affect Schedule (PANAS) scored 10 (lowest) - 50 (highest) Medication use: : daily dose ICS; concomitant oral corticosteroids (past 12 weeks); corticosteroid injections (previous 6 months); other prescribed medications Asthma status: : 6-item 6 Asthma Control Questionnaire (ACQ) scored 0-6; 0 number of emergency hospital visits for asthma (previous year) Demographics: : Smoking status and educational level
19 Results Self-reported patient characteristics * n=228 Age in years mean (SD) 43 (11.7) Female Sex 128 (56) Current daily dose ICS mean µg (SD) 948 (653) Current use of 1 or more concomitant drug 147 (65) Smoking status: Never / Former / Current 125 (55) / 85 (38) / 16 (7) ACQ (asthma control) score - median (IQR) 0.7 ( ) Hospital visits for asthma in last year 1 2 (1) No. medical co morbidities: None / 1 79 (35) / 149 (65) Education beyond high school 61 (27) *Data represent no. of subjects (%) unless otherwise specified.
20 Results ICQ side effect score by negative affectivity (NA) and dose group n Low NA n Average NA n High NA p-value ICS dose All doses ( ) ( ) ( ) <0.001 Low ( ) ( ) ( ) <0.001 Medium ( ) ( ) ( ) High ( ) ( ) ( ) p-value < Patients higher in NA reported significantly greater side effects than the groups of patients scoring lower on NA The ICS dose-response was affected by increasing NA regression analysis shows that both ICS dose and NA influence side effect reporting* Jonckheere-Terpstra test for comparison between low to high groups (highlighted bold); ICS=inhaled corticosteroid. * Regression results not shown see Foster JM et al. Resp Res 2006; 7:131;
21 Discussion A number of potential local and systemic side effects are associated with ICS use Patients may reduce or stop ICS use when they experience side effects Poor adherence to ICS is related to worse asthma control and increased health resource use
22 Discussion Patients report dose-related side effects of ICS However the patient s s personality is also an important factor in side effect reporting Personality influences self-rated symptoms as well as side effects If possible raise the topic of side effects in consultations because provision of advice about their management can reduce anxiety-driven symptom reporting 1,2 1. Kim Y et al. Support Care Cancer 2002; 10(5): ; 2. Williams P.G. et al. Pers Soc Psychol Bull 2002;28:
23 Thanks to my co-authors Prof. Thys van der Molen Prof. Robbert Sanderman Thomas Mueller Dr. Eric van Sonderen
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