Dataset Information

Development and initial validation of quality-of-life questionnaires for intermittent exotropia.

ABSTRACT:

Purpose

The development and initial validation of patient-derived, health-related quality-of-life (HRQOL) questionnaires for intermittent exotropia (IXT).

Design

Cross-sectional study.

Participants

In a development phase, 27 children (age, 2-17 years) with IXT and 1 of their parents. In an initial validation phase, 33 children with IXT and 49 control children (age, 5-17 years), along with 1 parent for each child. Children in the control group had no strabismus or amblyopia.

Methods

Individual patient interviews generated 35 items for child and proxy (parental assessment of child's HRQOL) questionnaires and 46 items for a parent questionnaire. To reduce to a feasible number of items, questionnaires were administered to 5- to 17-year-old children with IXT (n = 15) and parents of 2- to 17-year-old children with IXT (n = 27). Responses were analyzed using standard item reduction methodology. Three final derived IXT questionnaires (IXTQ): child, proxy, and parent (12, 12, and 17 items, respectively) were administered to children with IXT and control children and to parents of IXT and control children. Likert-type scales ranging from never (100, best HRQOL) to almost always (0, worst HRQOL) were used.

Main outcome measures

Median scores for IXT and control groups, compared using Wilcoxon tests.

Results

Median child scores were significantly lower (worse HRQOL) in the IXT group compared with the control group: 85 (quartiles, 73-92) versus 92 (quartiles, 79-96; P = 0.04). Median proxy IXTQ scores were significantly lower for IXT children than controls: 83 (quartiles, 75-94) versus 98 (quartiles, 92-100; P<0.0001). Median parent IXTQ scores also were significantly lower in the IXT group compared with the control group: 68 (quartiles, 56-79) versus 93 (quartiles, 87-99; P<0.0001).

Conclusions

A new 3-part patient-derived HRQOL questionnaire for children with IXT and their parents has been developed and validated, comprising child, proxy, and parent questionnaires. These questionnaires detect reduced HRQOL in children with IXT as reported by the children themselves and perceived by their parents (proxy report). Childhood IXT also seems to affect parent HRQOL. The IXTQ HRQOL questionnaires may prove useful in the clinical assessment of IXT and for clinical trials.

Financial disclosure(s)

The author(s) have no proprietary or commercial interest in any materials discussed in this article.

SUBMITTER: Hatt SR

PROVIDER: S-EPMC2815177 | biostudies-literature | 2010 Jan

REPOSITORIES: biostudies-literature

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Publications

Development and initial validation of quality-of-life questionnaires for intermittent exotropia.

Hatt Sarah R SR Leske David A DA Yamada Tomohiko T Bradley Elizabeth A EA Cole Stephen R SR Holmes Jonathan M JM

Ophthalmology 20091106 1

<h4>Purpose</h4>The development and initial validation of patient-derived, health-related quality-of-life (HRQOL) questionnaires for intermittent exotropia (IXT).<h4>Design</h4>Cross-sectional study.<h4>Participants</h4>In a development phase, 27 children (age, 2-17 years) with IXT and 1 of their parents. In an initial validation phase, 33 children with IXT and 49 control children (age, 5-17 years), along with 1 parent for each child. Children in the control group had no strabismus or amblyopia. ...[more]

PMID: 19896195

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Project description:BackgroundIntermittent exotropia (IXT) is the most common form of exotropia in children. In addition to cosmetic effects and loss of stereoscopic function, IXT may negatively impact the psychological well-being of children and their parents. The purpose of this study was to assess the patient-reported outcomes of Chinese children with IXT before and after strabismus surgery.MethodsThe records of children with IXT who underwent strabismus surgery at the Zhongshan Ophthalmic Center of Sun Yat-sen University, China over the period from January 1, 2016 to December 31, 2018 were prospectively recruited. All children underwent ophthalmic and orthoptic examinations, including the prism and alternate cover test, fusion function by synoptophore, stereoacuity and Newcastle control score. Two patient-reported outcome measures were used: the intermittent Exotropia Questionnaire (IXTQ) to measure disease-specific health-related quality of life (HRQOL) and the Hospital Anxiety and Depression Scale (HADS) to measure anxiety and depression. Patient-reported outcome measurements were made before and after surgery with responses from children and their parents.ResultsA total of 389 children were eligible for inclusion (47.8% male, 52.2% female, mean + SD age = 8.17 ± 2.81). Preoperative IXTQ scores in both children (48.21 ± 26.2) and their parents (44.6 ± 25.68) were significantly correlated with near stereoacuity (P = 0.029 and P = 0.015, respectively). The angle of deviation at near vision showed a negative linear relationship with visual function (P = 0.026) and psychological (P = 0.019) scores as well as opinions regarding surgery (P = 0.024). HADS scores (anxiety scale score: 11 ± 2.92, depression scale score: 10.44 ± 2.9) were also related to near stereoacuity (P < 0.05). After surgery, both children's (74.83 ± 16.59) and parents' (68.57 ± 17.06) IXTQ scores significantly improved (p<0.01). Children's IXTQ scores were related to the angle of deviation at distance, and their psychological and visual function scores showed a negative relationship with the angle of deviation at near vision (P < 0.05).ConclusionChildren and parents' HRQOL and HADS were associated with near stereoacuity. Parents usually attend more readily to the angle of deviation at near in their IXT children. HRQOL improved significantly after surgery and can be used as one of the indices for preoperative evaluation but is not recommended as a criterion for surgical intervention.

Project description:BackgroundThe clinical management of intermittent exotropia has been discussed extensively in the literature, yet there remains a lack of clarity regarding indications for intervention, the most effective form of treatment and whether or not there is an optimal time in the evolution of the disease at which any treatment should be carried out.ObjectivesThe objective of this review was to analyse the effects of various surgical and non-surgical treatments in randomised trials of participants with intermittent exotropia, and to report intervention criteria and determine the significance of factors such as age with respect to outcome.Search methodsWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library, Issue 4, 2012), MEDLINE (January 1966 to May 2012), EMBASE (January 1980 to May 2012), Latin American and Caribbean Literature on Health Sciences (LILACS) (January 1982 to May 2012), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov) and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 4 May 2012. We are no longer searching the UK Clinical Trials Gateway (UKCTG) for this review. We manually searched the British Orthoptic Journal up to 2002, and the proceedings of the European Strabismological Association (ESA), International Strabismological Association (ISA) and American Academy of Paediatric Ophthalmology and Strabismus meeting (AAPOS) up to 2001. We contacted researchers who are active in the field for information about further published or unpublished studies.Selection criteriaWe included randomised controlled trials of any surgical or non-surgical treatment for intermittent exotropia.Data collection and analysisEach review author independently assessed study abstracts identified from the electronic and manual searches. Author analysis was then compared and full papers for appropriate studies were obtained.Main resultsWe found one randomised trial that was eligible for inclusion. This trial showed that unilateral surgery was more effective than bilateral surgery for correcting the basic type of intermittent exotropia.Authors' conclusionsThe available literature consists mainly of retrospective case reviews, which are difficult to reliably interpret and analyse. The one randomised trial included found unilateral surgery more effective than bilateral surgery for basic intermittent exotropia. However, across all identified studies, measures of severity and thus criteria for intervention are poorly validated, and there appear to be no reliable natural history data. There is therefore a pressing need for improved measures of severity, a better understanding of the natural history and carefully planned clinical trials of treatment to improve the evidence base for the management of this condition.

Project description:BackgroundThe aim of our study was to develop and validate the first set of PKU-specific Health-related Quality of Life (HRQoL) questionnaires that: 1) were developed for patients with PKU and their parents, 2) cover the physical, emotional, and social impacts of PKU and its treatment on patients' lives, 3) are age specific (Child PKU-QOL, Adolescent PKU-QOL, Adult PKU-QOL), 4) enable the evaluation of the HRQoL of children by their parents (Parent PKU-QOL), and 5) have been cross-culturally adapted for use in seven countries (i.e. France, Germany, Italy, The Netherlands, Spain, Turkey and the UK).MethodsThe PKU-QOL questionnaires were developed according to reference methods including patients', parents' and healthcare professionals' interviews; testing in a pilot study (qualitative step in six countries), and linguistic validation of the finalised pilot versions in Turkish. For finalisation and psychometric validation, the pilot versions were included in a multicentre, prospective, non-interventional, observational study conducted in 34 sites in France, Germany, Italy, The Netherlands, Spain, Turkey and the UK. Iterative multi-trait analyses were conducted. Psychometric properties were assessed (concurrent and clinical validity, internal consistency reliability and test-retest reliability).ResultsData from 559 subjects (306 patients, 253 parents) were analysed. After finalisation, the PKU-QOL questionnaires included 40 items (Child PKU-QOL), 58 items (Adolescent PKU-QOL), 65 items (Adult PKU-QOL) and 54 items (Parent PKU-QOL), distributed in four modules: PKU symptoms, PKU in general, administration of Phe-free protein supplements and dietary protein restriction. The measurement properties of the Adolescent, Adult and Parent PKU-QOL questionnaires were overall fairly satisfactory, but weaker for the Child questionnaire.ConclusionsThe four PKU-QOL questionnaires developed for different ages (Child PKU-QOL, Adolescent PKU-QOL, Adult PKU-QOL), and for parents of children with PKU (Parent PKU-QOL) are valid and reliable instruments for assessing the multifaceted impact of PKU on patients of different age groups (children, adolescents and adults) and their parents, and are available for use in seven countries. They are very promising tools to explore how patients' perceptions evolve with age, to increase knowledge of the impact of PKU on patients and parents in different countries, and to help monitor the effect of therapeutic strategies.

Dataset Information

Development and initial validation of quality-of-life questionnaires for intermittent exotropia.

Purpose

Design

Participants

Methods

Main outcome measures

Results

Conclusions

Financial disclosure(s)

Publications

Development and initial validation of quality-of-life questionnaires for intermittent exotropia.

Similar Datasets

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