Measuring quality of life in children with rhinoconjunctivitis

doi:10.1016/S0091-6749(98)70380-X

Journal of Allergy and Clinical Immunology

Volume 101, Issue 2, February 1998, Pages 163-170

https://doi.org/10.1016/S0091-6749(98)70380-X Get rights and content

Abstract

Objective: The objective of this study was to develop, pretest, and validate a questionnaire to measure quality of life in children with seasonal allergic rhinoconjunctivitis (SAR).

Methods (development study): Thirty-four children with SAR were enrolled from summer camps, notices in the media, and an allergy clinic (Southern Ontario). After generating a pool of 48 potentially important quality of life items, the children identified the ones that they experienced with their SAR and scored each for bother (1 = a little bothered to 4 = extremely bothered). Items identified most frequently and with the highest bother score were included in the Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ). The PRQLQ was pretested for ease completion and accuracy of understanding.

Results (development study): The PRQLQ has 23 items in five domains (nose symptoms, eye symptoms, practical problems, other symptoms, and activities). Responses are given on a seven-point scale, and children are asked to score their experiences during the previous 7 days.

Methods (validation study): Seventy-five children with symptomatic SAR were enrolled from notices in the media and a pediatric allergy clinic (Austin, Tex.). A single cohort design was used, with children assessed at 0, 1, and 3 weeks. The PRQLQ was administered to the children by a trained interviewer at 1 and 3 weeks. A conventional nasal symptom daily diary was completed for 1 week before each of these clinic visits. Global ratings were completed at the final visit.

Results (validation study): In patients who were stable between clinic visits, the PRQLQ demonstrated good reliability (intraclass correlation coefficient = 0.93). The questionnaire was very responsive to change (p < 0.001) and was able to differentiate between patients who were in a stable clinical state and those whose clinical state changed between visits (p = 0.005). Correlations between the PRQLQ and diary scores were close to predicted and supported both the cross-sectional and longitudinal validity of the PRQLQ.

Conclusions: The PRQLQ measures the quality of life impairments important to children with SAR. Children provide reliable and accurate responses, the measurement properties are strong, and the questionnaire can be used with confidence in clinical trials, clinical practice, and surveys. (J Allergy Clin Immunol 1998;101:163-70.)

Section snippets

METHODS

The development and testing of the PRQLQ required two separate studies, and these were conducted in different locations and used different subjects. The methods for the two studies are presented separately.

Item reduction phase

All 34 children enrolled in the study completed the questionnaire and provided complete data sets. There were 16 females and 18 males, with a mean age of 9.7 years (SD = 1.8 years). Fifteen children were currently taking an antihistamine for their rhinoconjunctivitis, two were using an inhaled nasal steroid, four were using a nonsteroidal nasal spray, one was taking eye drops, and four were using a combination of medications. Eight children were not currently taking any medications but had

DISCUSSION

In the questionnaire development study, the children (6 to 12 years old) were very consistent in their responses to the item reduction questionnaire. This consistency allowed us to construct the PRQLQ with confidence. We found that many children are very bothered by nasal, ocular, and systemic symptoms and the practical nuisance of having symptoms. In these domains, they were very similar to adults and adolescents with rhinoconjunctivitis.1, 7 However, the item reduction data showed that these

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The study was conducted to investigate the effects of a nursing intervention aimed at home environment modification on symptom control, quality of life, and the number of triggers in children with allergic rhinitis.
This one-to-one, parallel-arm, randomized controlled trial was conducted with a pre-test/post-test design. The study used stratified sampling method. A total of 52 participants were randomly assigned to the intervention group (n = 26) and the control group (n = 26). The intervention group received education on home environment modification and the child was provided with anti-allergic bedding set. The control group continued with routine practices. Statistical significance was set at p < 0.05.
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The findings indicate that the nursing intervention for home environment modification is an effective method in reducing the number of triggers in the home environment. However, no significant impact was observed on symptom control and quality of life.
Awareness can be increased by educating children with allergic rhinitis and their families about triggers in the home environment.
Efficacy and safety of GSP301 nasal spray in children aged 6 to 11 years with seasonal allergic rhinitis
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GSP301 nasal spray is a fixed-dose combination of the antihistamine olopatadine hydrochloride and the corticosteroid mometasone furoate.
To evaluate the efficacy, safety, and tolerability of GSP301 in pediatric patients (aged ≥6 to <12 years) with seasonal allergic rhinitis (SAR).
This double-blind, randomized, parallel-group study randomized 446 eligible patients 1:1 (GSP301 [olopatadine hydrochloride 665 μg and mometasone furoate 25 μg] or placebo) as 1 spray/each nostril twice daily for 14 days. The primary end point was change from baseline in average morning and evening subject-reported 12-hour reflective Total Nasal Symptom Score (rTNSS) over a 14-day treatment period analyzed using mixed-effect model repeated measures. Additional assessments included instantaneous Total Nasal Symptom Score, Pediatric Rhinoconjunctivitis Quality of Life Questionnaire, reflective Total Ocular Symptoms Score, instantaneous Total Ocular Symptoms Score, individual symptoms, Physician-assessed Nasal Symptom Score, and adverse events.
GSP301 showed clinically meaningful and statistically significant improvement in rTNSS vs placebo (−0.6; 95% confidence interval, −0.9 to −0.2; P = .001). Statistically significant improvements favoring GSP301 were shown for all individual rTNSS symptoms, instantaneous Total Nasal Symptom Score, and most of its individual symptoms, Physician-assessed Nasal Symptom Score (P = .01), and Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (P < .001). For ocular symptoms, numerical improvements favoring GSP301 were observed, with statistical significance achieved only for reflective “tearing/watering eyes” (P = .04). Treatment-emergent adverse events occurred in 12.0% and 10.4% of patients in the GSP301 and placebo groups, respectively. One subject (0.5%) (placebo group) experienced a serious adverse event (suspected viral meningitis) that was not related to the study treatment and was resolved.
GSP301 was well tolerated and efficacious for treating SAR symptoms in pediatric patients and showed a favorable safety profile.
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Engaging the Voices of Children: A Scoping Review of How Children and Adolescents Are Involved in the Development of Quality-of-Life–Related Measures
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Patient-reported outcomes are increasingly recommended to guide patient care, develop and evaluate interventions, and modify health systems. However, not enough is known about whether and how children and adolescents, as “experts” in their own health and quality of life (QoL), are being engaged in the development of instruments. Our goals in this review were (1) to identify all QoL-related instruments that have included children and/or adolescents in the development of questionnaire content, including identification of themes and items; and (2) to report how this was done; and (3) to highlight those that used qualitative methods.
MEDLINE and Embase were searched for child- or adolescent-completed QoL-related instruments, supplemented by hand-searching of relevant reviews until 2020. Original development papers were identified and retrieved when possible, from which instrument characteristics and details of qualitative development methods were extracted.
We identified 445 instruments, of which 88 used qualitative methods for content development. Interviews and focus groups were the most common methods. A variety of play techniques were used to engage the child and adolescent participants. The specific criteria for the inclusion of children and adolescents (age, developmental stage, duration, and nonclinical location) varied considerably.
Researchers frequently involve children and adolescents in qualitative methods when developing QoL-related measures; however, there is little information about the methods used. Better reporting of methodology, improved dissemination of methods guidelines, and research into optimal ways of including children and adolescents in the process of instrument development would be useful.
Active smoking effect in allergic rhinitis
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Cross-sectional study in adult smokers and non-smokers, with a clinical diagnosis of AR and positive Skin Prick Test (SPT). Smoking status was confirmed by salivary cotinine measurements. Functional respiratory evaluation was performed, and quality of life between groups was compared using Mini-RQLQ questionnaire. Immunological markers in serum and nasal washes (IgE, IL-4, IL 5, IL 13, IL 17, IL 33) were evaluated, while samples from a third group of passive smokers was incorporated for serological comparison exclusively. The statistical analysis included Student T test, x2, Mann Whitney U (Anova 2-way), and Kruskal Wallis for 3 groups analysis. Values of P < 0.05 were considered significant.
Twenty-two patients per group with similar demographics and allergen sensitivity were studied. Regarding inflammatory markers, a reduction of IL 33 in the serum of smokers (P < 0.001) was the only statistically significant different parameter revealed, showing a remarkable trend in nasal lavage. Salivary cotinine levels were absolutely different (P < 0.0001), but pulmonary function evaluations were not statistically significant after multiple adjusting. There were no significant differences in quality of life parameters.
In our study of AR, active smokers do not demonstrate impaired nasal related quality of life or impact on atopic inflammatory parameters, compared to non-smokers. Reduced levels of IL33 could explain a lack of symptoms alerting smokers of the harmful consequences of smoking.
Quality of life assessment in patients treated with nasal corticotherapy for allergic rhinitis: A cohort study
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Citation Excerpt :
The RQLQ is the questionnaire we chose for our study for its excellent performance in the large evaluating clinical studies, in the patients follow up and in the evaluation of the medical care. Besides, it had been used in many studies to evaluate the effect of nasal corticotherapy [24]. The questionnaire has been established by Professor Elizabeth Juniper.
Allergic rhinitis (AR) is a chronic nasal pathology induced by an inflammation of the mucous membranes due to a dependent IgE reaction following allergenic exposure. The main symptoms are rhinorrhea, nasal itching, nasal obstruction and sneezing bursts. It highly affects the patient quality of life (QoL) in many levels making it a public health issue.
The aim of this study is to assess the QoL of patients with AR as well as the level of its improvement after nasal corticotherapy.
From June 2019 to February 2020, a prospective study was carried out based on the use of the validated Arabic version of the RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire) on a cohort of AR patients to measure their QoL before and after three months of treatment by “Budesonide”.
A total of 70 patients participated in the study with an average age of 39.54 years with a sex ratio of 0.60. Their total RQLQ score was up to 4.28, improved to 2.35 after treatment. Also, a statistically significant improvement in sub-scores was also observed (p < 0.001): activities (from 4.43 to 2.29), nasal symptoms (from 5.00 to 2.80), eye symptoms (from 3.38 to 1.80), practical problems (from 4.29 to 2.18), general problems (from 4.63 to 2.78) and emotional state (from 4.28 to 2.43).
The RQLQ is a reliable tool to evaluate the QoL in AR patients, stating the negative influence of AR on patients daily life and the effectiveness of nasal corticosteroid treatment.
Interest of environmental exposure chambers in the evaluation of allergic conjunctivitis
2020, Journal Francais d'Ophtalmologie
Les conjonctivites allergiques concernent 15 à 20 % de la population générale. Son évaluation se fait à l’heure actuelle par les tests de provocation conjonctivale (TPC), qui constituent le mètre étalon. Les chambres d’exposition environnementale (CEE) sont largement utilisées dans l’étude de la rhinite et de l’asthme allergiques. Leur utilisation pourrait être étendue aux conjonctivites allergiques en tant qu’alternative au TPC dans le développement des médicaments. Cependant, l’évaluation de la réponse à l’allergène lors des tests de provocation individuels ou dans les CEE est encore sujette à discussion en raison de la multiplicité des scores de symptômes. Il existe de très nombreux scores utilisés pour évaluer la conjonctivite allergique. Les critères principaux utilisés ont été décrits par Abelson en 1990, et incluent la rougeur, le prurit, le larmoiement, et l’œdème. Le TOSS est le score spécifiquement oculaire le plus souvent utilisé dans les études. Peu de traitements ont été évalués en CEE, parmi lesquels on peut citer l’application de compresses froides, l’épinastine et le N-acetyl aspartyl glutamic acid. Par ailleurs, les premières données montrent une bonne corrélation entre les symptômes oculaires obtenus dans les CEE et ceux lors d’exposition naturelle. Les CEE pourraient être une alternative valable aux TPC et constituent un bon reflet de l’exposition allergénique saisonnière naturelle. Enfin, elles seraient également utilisables dans d’autres domaines, comme l’étude du syndrome sec oculaire.
Allergic conjunctivitis affects 15 to 20% of the general population. It is currently evaluated by the Conjunctival Provocation Test (CPT), which is considered as the gold standard. In the investigation of allergic rhinitis and asthma, environmental exposure chambers (EEC) are increasingly utilised. For allergic conjunctivitis, EEC might be a valid alternative to the CPT. However, evaluation of the allergen response in individual provocation tests or in EECs is still in discussion due to the multiplicity of symptom scores. Indeed, there are many scores used to evaluate allergic conjunctivitis. The main criteria used were described by Abelson in 1990 and include redness, itching, tearing, and swelling. In clinical studies, the specifically ocular score most used is the Total Ocular Symptom Score (TOSS). Few treatments have been evaluated by EEC, including cold compresses, epinastine and N-acetyl aspartyl glutamic acid. Moreover, early data shows good correlation between ocular symptoms induced in an EEC and those assessed during natural exposure. EEC might be a valid alternative to CPT and correlate with natural seasonal allergen exposure. Finally, EEC might be useful in other fields as well, such as in the study of dry eye disease.

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^☆: From ^athe Department of Clinical Epidemiology and Biostatistics, McMaster University Faculty of Health Sciences, Hamilton, Ontario; ^bHealthquest Therapy and Research Institute Inc., Austin; and ^cHealth Outcomes Research, Hoechst Marion Roussel Inc., Kansas City.

^☆☆: Supported by a grant from Hoechst Marion Roussel Inc.

^★: Reprint requests: Elizabeth Juniper, MCSP, MSc, Department of Clinical Epidemiology and Biostatistics, McMaster University Medical Centre, 1200 Main St. West, Hamilton, Ontario, L8N 3Z5, Canada.

^★★: 1/1/86354

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Measuring quality of life in children with rhinoconjunctivitis☆,☆☆,★,★★

Abstract

Section snippets

METHODS

Item reduction phase

DISCUSSION

J Allergy Clin Immunol

J Allergy Clin Immunol

J Clin Epidemiol

J Clin Epidemiol

Development and testing of a new measure of health status for clinical trials in rhinoconjunctivitis

Clin Exp Allergy