Current Eye Research, Early Online, 1–7, 2015 ! Informa Healthcare USA, Inc. ISSN: 0271-3683 print / 1460-2202 online DOI: 10.3109/02713683.2015.1011280
RESEARCH REPORT
Longitudinal Impact on Quality of Life for School-aged Children with Amblyopia Treatment: Perspective from Children Yanyan Chen1, Xinhong Chen1, Jie Chen1, Jingwei Zheng2, Jinling Xu1, and Xinping Yu1 Curr Eye Res Downloaded from informahealthcare.com by Kainan University on 04/28/15 For personal use only.
1
Department of Amblyopia and Strabismus, Eye Hospital of Wenzhou Medical University, Wenzhou, China and 2 Clinical Research Center, Eye Hospital of Wenzhou Medical University, Wenzhou, China
ABSTRACT Background: To evaluate the longitudinal impact on health-related quality of life (HRQOL) during amblyopia treatment for school-aged children from children’s perspective. Methods: School-aged children prescribed amblyopia treatment for the first time were recruited into the current study. Using a questionnaire, subjects’ HRQOL was assessed before patching treatment, and at 8 weeks and 16 weeks after the commencement of patching treatment. Evaluation of visual function and psychosocial aspect was included in the questionnaire. Visual acuity and demographic data of the subjects were recorded. Results: Forty-four children, aged 7–12 years, with anisometropic amblyopia were included in the study. Visual acuity in the amblyopic eye improved 1.90 (0.41–3.74) and 3.98 (2.22–5.11) lines at follow-up weeks 8 and 16, respectively. Both the total score and subscales of the questionnaire were reduced at the first follow-up and recovered at the second follow-up. Scores at week 16 were higher than those before treatment in the psychosocial aspect (p = 0.003), and lower in the visual function aspect (p50.001), without significant difference in total score (p = 0.207). Visual acuity in the amblyopic eye and psychosocial expectations for treatment were the most important factors that influenced HRQOL during treatment. Conclusions: From the children’s perspective, the impacts on visual function and psychosocial aspect were significant in the first two months of treatment, and could be adapted during therapy for school-aged children. More attention should be paid to negative effects of treatment on daily life and study at the stage of amblyopia treatment for school-aged children. Meanwhile, necessary precautions should be taken to help reduce the impacts. Keywords: Amblyopia treatment, health-related quality of life, school-aged child
BACKGROUND
emotional and psychological well-being and selfesteem of children and their families.7–12 Several studies assessed the impact of amblyopia treatment on health related quality of life (HRQOL). For example, the Pediatric Eye Disease Investigator Group (PEDIG) reported that 3–6 year-old children with moderate amblyopia and their parents could tolerate patching treatment during 5 weeks of treatment.13 Sabri et al.7 found that an unpleasant patching experience during childhood could have a negative psychological impact on teenagers. Almost all
Amblyopia is an impairment of best-corrected visual acuity (BCVA) due to the interruption of normal visual development. The prevalence of amblyopia varies from 0.08% to 5.4% of the population among the different races, ethnicities and ages.1–6 The main treatments for amblyopia include correcting refractive error, atropine penalization and patching the sound eye. However, it is increasingly recognized that amblyopia treatment may negatively affect the
Received 25 February 2014; revised 8 December 2014; accepted 18 January 2015; published online 17 March 2015 Yanyan Chen and Xinhong Chen contributed equally to this work. Correspondence: Xinping Yu, Department of Amblyopia and Strabismus, Eye Hospital of Wenzhou Medical University, No. 270, West Xueyuan Rd., Wenzhou 325027, China. Tel: +86 577 88068831. Fax: +86 577 88824115. E-mail: [email protected]
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questionnaires were completed either by the parents of the children under treatment, or by teenagers or adults from their long-term memory.7,13,14 To the best of our knowledge, few HRQOL studies focused on school-aged children undergoing amblyopia treatment from the child’s perspective,11,15,16 as treatment could cause them more negative effects with respect to their daily life and social life. A child’s functional vision decreases to that of the amblyopic eye when the sound eye is covered with an eye patch.17 Study of the longitudinal impact of amblyopia treatment, from beginning to during of the treatment, on school-aged children is limited. We developed a condition-specific questionnaire, and the reliability and validity of the questionnaire were evaluated in our previous study.18 In this study, we investigated the longitudinal impact on HRQOL using the questionnaire for school-aged children during amblyopia treatment.
instructions and without data missing. The two subscales, visual function aspect (6 items) and psychosocial aspect (10 items), were grouped into four principal factors identified through exploratory factor analysis: (1) visual function (6 items); (2) psychosocial impact (6 items); (3) social interaction (2 items) and (4) worries about vision (2 items). We conducted a validation study of the questionnaire and found a cumulative variance of 72.8%. The test–retest reliability (intra-class correlation coefficient, ICC), split-half reliability and Cronbach’s alpha coefficient of the questionnaire were 0.907, 0.907 and 0.883, respectively.18 The items of the questionnaire (Chinese translated into English) are shown in Supplementary 1. Each of the items was scored (0, 25, 50, 75 or 100) according to a 5-point Likert scale, with higher scores (i.e. ‘‘100’’) indicating better HRQOL. For each patient, mean overall score (i.e. the mean of 16 items), mean scores for visual function (6 items) and psychosocial impact (10 items) were calculated.
MATERIALS AND METHODS Ethics statement: The study was approved by the Affiliated Eye Hospital of Wenzhou Medical College Ethics Committee and adhered to the tenets of the Declaration of Helsinki. Recruitment was entirely voluntary, and written informed consent was obtained from the participating children’s parents or their guardians before the study. There was no financial or other form of incentive for the subjects to participate in the study.
About the Questionnaire The questionnaire was designed to provide a method to assess the impact of amblyopia treatment on HRQOL through the perspective of children undergoing amblyopia treatment. The items in the questionnaire were developed on the basis of scientific literature about the impact of amblyopia treatment on HRQOL and clinical experience. The questionnaire initially included 22 items. Several specialists in pediatric eye care, a pediatric psychologist, a statistician and 12 children aged 7–12 years currently receiving with amblyopia treatment and their parents reviewed the initial items for content validity. Eighty-eight children aged 7–12 years undergoing amblyopia treatment, who were recruited in the Strabismus and Amblyopia Department of Eye Hospital of Wenzhou Medical College, completed the questionnaire. The reliability, validity and responsibility of the scale were assessed through dispersion analysis, factor analysis and correlation coefficient. A 16-item questionnaire for children aged 7–12 years with amblyopia treatment was finalized. Children could complete the questionnaire with limited verbal
Longitudinal Impact on Quality of Life for Children with Amblyopia Treatment From March 2009 to October 2009, children were recruited for this study from the Strabismus and Amblyopia Department of the Eye Hospital of Wenzhou Medical College. The eligibility criteria included: (1) children aged 7–12 years, (2) diagnosed with amblyopia for the first time, (3) anisometropic amblyopia, to exclude the effect of strabismus on children’s HRQOL, (4) BCVA of amblyopia eye better than 0.05 in Snellen (1.3 in logMAR), (5) had received no amblyopia treatment before and (6) had no ocular pathology or learning difficulties. The exclusion criteria included: (1) with obvious strabismus (larger than 10 prism diopter, PD), (2) BCVA of amblyopia eye less than 0.05 in Snellen (1.3 in logMAR), (3) with history of ocular surgery and (4) with ocular pathology, such as congenital cataract or glaucoma. All patients had a period of 6 weeks for refractive adaptation to decide the necessity of patching treatment. Patients were then prescribed patching treatment, 4–6 h patching daily (including some time in school), as well as performing near activities for at least 1–2 h during patching. All children were instructed to wear the patch while reading, doing written homework or working on the computer. The parents or guardians recorded the reported patching time per day. BCVA of both the sound eye and the amblyopic eye was recorded before patching treatment, and 8 weeks and 16 weeks after amblyopia treatment with vision chart projector. Functional Visual Acuity (VA) before treatment was defined as VA tested with both eyes open with wearing glasses. Functional VA during Current Eye Research
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Impact of Amblyopia Treatment on QOL 3 treatment was defined as the corrected VA of the amblyopic eye. The questionnaire was completed before patching treatment (with 6 weeks of refractive adaptation) and 8 weeks and 16 weeks after the beginning of amblyopia treatment. At each interview time, the questionnaire was completed in the waiting room before examination. All of the recruited children were asked to complete the questionnaire in the presence of their parents or guardians. Before each interview, the children, their parents or guardians were asked to assess their child’s cooperation in wearing glasses and patching during treatment time. Questionnaires were self-administered with written instructions and were supervised by the same investigator (CXH). If a child did not understand a question, it was read verbatim by CXH without any explanation or elaboration. Inability to respond despite repetition of a question was recorded as ‘‘I don’t know’’. Parents were instructed not to interfere with their child’s responses, and communication (verbal or nonverbal) between child and parent was denied by positioning the parent behind the child.
Statistical Analyses Patients with the who were non-compliant with treatment for the following reasons were excluded from data analysis: glasses wear less than half of waking hours, patching time less than 1.5 h/day and cessation of treatment (spectacle wear or patching) before the planned follow-up time. Analysis of variance of repeatedly measured data was performed to compare HRQOL before and after treatment. Spearman rank correlation analysis was used to investigate the correlation between functional VA and scores of HRQOL. Univariate analyses were performed, including gender and age treated as independent variables. Generalized estimating equation analysis was used to analyze the influence factors for HRQOL during treatment, e.g. the average reported patching time per day. Visual acuity in Snellen was translated to logMAR for statistic analysis. A p 0.05 (two-tailed) was considered statistically significant. No child had ‘‘I don’t know’’ responses for each subscale by the time point. All statistical analyses were performed using software SPSS 12.0 (SPSS, Chicago, IL, USA).
RESULTS Demographic Data of the Subjects Forty-five children were recruited into the study, but one 11-year-old boy with anisometropic amblyopia was excluded from the analysis at the 8th-week !
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TABLE 1 Characteristics of 44 amblyopia children with treatment.
Gender Male Female Age (years)
N
%
21 23 7–12 (8.43 ± 1.34)
48 52
Visual acuity of amblyopic eye (in logMAR) 0.1–0.2 6 0.3–0.7 19 40.7 19
14 43 43
follow-up for uncooperativeness and discontinuation of the patching treatment. Therefore, 44 children were included in the study. Their parents or guardians considered their children to be cooperative, or cooperative most of the time, in the treatment at both follow-up points. Table 1 shows the demographic data of the 44 subjects. Three to eight (4.5 ± 2.7) lines of the interocular difference (IOD) were observed in all of the patients and all had a VA of 0.1 to 0.1logMAR (median, 0 logMAR) in the sound eye. Five patients had a 3.5 to 9.0 D myopic difference and 39 had a 1.5 to 9.0 D (5.0 ± 2.0) hypermetropic difference between the two eyes. With 8 weeks and 16 weeks of patching treatment, VA of the amblyopic eyes improved 1.90 (0.41–3.74) and 3.98 (2.22–5.11) lines, respectively.
HRQOL Changes during Amblyopia Treatment As is shown in Table 2, the scores of both total scale and the two subscales were the lowest at the 8th week of treatment compared to pre-treatment and the 16th week of treatment. At the 16th week, the scores were significantly higher than pre-treatment in the psychosocial aspect (p = 0.003), but remained lower in visual function (p50.001), and no significant differences were found in total scale (p = 0.207; Figure 1).
Association of HRQOL with the Characteristics of Children There was no significant difference between gender (t = 1.96, p = 0.07 at 8 weeks and t = 1.86, p = 0.08 at 16 weeks) and age (t = 0.80, p = 0.43 at 8 weeks and t = 1.84, p = 0.07 at 16 weeks) to the scores of HRQOL. At the 16th week of treatment, children 7 to 5 9 years had better visual function subscales than those aged 9–12 years (p = 0.012). Correlations were statistically significant between functional VA and total HRQOL (r = 0.576, p50.001 at 8 weeks, and r = 0.602, p50.001 at 16 weeks), visual function subscales (r = 0.756, p50.001 at 8 weeks, and r = 0.723,
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TABLE 2 Analysis of variance of repeated measures. Scale scores (x ± S) Domain
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Visual function Psychosocial aspect Total HRQOL
p
Pre-treatment (a)
With treatment 8 weeks (b)
With treatment 16 weeks (c)
F
p
a&b
a&c
b&c
90.06 ± 9.65 79.72 ± 12.64 83.59 ± 9.27
40.53 ± 21.70 67.73 ± 17.93 57.53 ± 14.05
74.91 ± 19.78 84.94 ± 9.59 81.18 ± 11.41
102.437 37.662 105.669
50.001 50.001 50.001
50.001 50.001 50.001
50.001 0.003 0.207
50.001 50.001 50.001
FIGURE 1 Functional visual acuity and HRQOL changes from baseline to 16 weeks.
p50.001at 16 weeks) and psychosocial function (r = 0.246, p = 0.005 at 8 weeks, r = 0.221, p = 0.008 at 16 weeks).
Influence Factors of HRQOL during Amblyopia Treatment Influence factors of HRQOL in amblyopia treatment through generalized estimating equation analysis are shown in Table 3. VA of the amblyopic eye, total QOL scores of pre-treatment and follow-up times (such as 8 weeks and 16 weeks) were the main factors influencing the children’s HRQOL during amblyopia treatment. While the psychosocial scores before treatment and the treatment duration were the main factors affecting the psychosocial aspect during treatment, visual acuity of the amblyopic eye and the treatment duration were the main factors influencing the visual function scores.
DISCUSSION Similar to Sabri et al.,7,19 we found that anisometropic amblyopia impacted children’s HRQOL minimally before treatment. However, HRQOL worsened at the beginning of patching, and recovered with the passage of time and with visual improvement of the amblyopic eye. In general, HRQOL changed with the
improvement in children’s functional vision. In addition, the psychosocial expectation before treatment also had an influence on their social psychology, especially during the first 2 months of treatment. Most studies regarding the impact of amblyopia treatment on HRQOL were based on interviews with children’s parents or guardian, which may not fully reflect the HRQOL condition of children during treatment, particularly in relation to their situation at school or nursery. A more comprehensive investigation from the perspective of children could be performed from different aspects, such as changes in visual function, psychosocial impact and social interaction at school. Study through interviews with parents showed that, during amblyopia treatment, preschool children were happy, cooperative and experienced no problems at nursery.12 Both patching and atropine treatment were well tolerated by 3–6-year-old children.13 However, studies from the perspective of 3–15 years old children revealed more adverse effects of treatment on their social psychology.16 Furthermore, these children had significantly lower self-perception of social acceptance or changes in subjective visual and psychological functions compared with age-matched control subjects.7,11 From the study of PEDIG in 7 to 513 years old children, the social stigma subscale scores on the Parent ATI and Child ATI were poorly correlated, though the overall and adverse effects and treatment compliance subscale scores were moderately to Current Eye Research
Impact of Amblyopia Treatment on QOL 5 TABLE 3 Generalized estimating equation analysis result of influence factors. Domain Total HRQOL
Visual function
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Psychosocial aspect
Factors
Coefficients
Total QOL scores before treatment Age Gender VA of amblyopic eye Patching timea Follow-up timeb Visual function scores before treatment Age Gender VA of amblyopic eye Patching timea Follow-up timeb Psychosocial scores before treatment Age Gender VA of amblyopic eye Patching timea Follow-up timeb
0.565 0.687 3.862 21.899 0.592 23.651 0.077 4.584 0.372 46.354 6.796 34.375 0.603 1.278 3.970 3.260 4.065 17.216
Std. Error 0.100 0.994 2.872 5.182 2.594 2.035 0.139 4.339 1.464 9.174 4.209 3.364 0.093 1.231 3.209 6.139 2.893 2.227
p 50.0001 0.490 0.179 50.0001 0.819 50.0001 0.582 0.291 0.799 50.0001 0.106 50.0001 50.0001 0.299 0.216 0.595 0.160 50.0001
a
Patching time refer to the number of hours patched. Follow-up time refer to the actual time points at which the child was examined.
b
well correlated.15 Therefore, it was necessary to evaluate the HRQOL impact from the perspective of children themselves. We evaluated the longitudinal changes of impact on HRQOL of amblyopia throughout treatment: prepatching and two times point during treatment. Previous studies of the longitudinal impacts did not cover the HRQOL during the treatment.8,10,11,13,15 VA of the amblyopic eye was considered the most important factor affecting the HRQOL of school-aged children undergoing treatment. While the PEDIG study found no difference in HRQOL among children with different levels of baseline VA and VA improvement in the amblyopic eye after 5 weeks of therapy,13 our research rendered different results. The discrepancy might be attributed to differences in interviewing questions, and the age of recruited subjects. The PEGIG study was based on interviews with parents, while the current study was based on the perceptions of children themselves. In addition, PEDIG study enlisted preschool children, while the subjects in this study were all school-aged. It was suggested that preschool children receiving patching treatment are less likely to be self-conscious or feel ashamed than school-aged children.11 In a PEDIG study for 7–12 years old children, the VA in amblyopic eye was improved significant, while the HRQOL reported by parents was similar in 5 weeks and 17 weeks followup.20 It maybe because of impact on HRQOL would be less significant in the PEDIG study than it in our study, for the patching time was 2 h per day in the PEDIG study, and the changes of HRQOL should be less in the PEDIG study with the VA improvement. The questionnaire used in the study was developed specifically for the school-aged children with amblyopia treatment. There are three other questionnaires !
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concerning HRQOL in amblyopia, the ATI (Amblyopia Treatment Index), the A&SQ (Amblyopia and Strabismus Questionnaire) and CVFQ (Children’s Visual Function Questionnaire). While a child version of ATI has been described, which includes treatment difficulty, adverse event and social stigma subscales, the study also described to use the ATI for 7–13 years old children.15 Except in 2014, there was no Chinese version ATI.21 The A&SQ is a useful instrument for assessing overall HRQOL effects of amblyopia and strabismus on adults, but none of the questions in the A&SQ assess the impact of treatment.22 CVFQ has a treatment difficulty subscale and a family impact subscale that can be used to assess the impact of treatment on both children and their family. A previous study reported that patching therapy for patients with unilateral aphakia significantly increased the scores on the treatment difficulty subscale, and suggested that CVFQ was sensitive to changes in treatment,23 whereas the CVFQ is a proxyreported outcome measurement. HRQOL is affected in the first few months of amblyopia treatment. Clinicians and guardians should pay close attention to these children, especially in the early stage of treatment. A previous study suggested that a balance between managing amblyopia and ensuring a child’s psychosocial well-being should be taken into consideration by clinicians and should be included in treatment guidelines.16 Part time patching, atropine penalization and Bangerter treatment would be consideration for the lower burden on children.24–27 There are some limitations to this study. The impact of strabismus upon HRQOL of children may be different from that of amblyopia. Strabismus is significantly associated with worse general HRQOL,
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while no association has been found between amblyopia and the general HRQOL in preschool children.19 Patients with strabismus had higher prevalence of abnormal binocular and eccentric fixation, which were the main factors influencing amblyopia treatment outcome.28 So it will be more difficult for treatment of amblyopia with strabismus in schoolaged children. Children with strabismic amblyopia should be recruited to evaluate the HRQOL impact of amblyopia treatment in future study. In contrast, a longer evaluation term is necessary since the results might not be stabilized with only 16 weeks of followup. Moreover, we did not evaluate the impacts of treatment from the perspective of the children’s family, and we failed to address the treatment difficulty or family impact, which is one of the important concerns during the amblyopia treatment.8,13,15 In further studies, the correlation between both perspectives should be taken into full account. In the study, we instructed the children to include some of the prescribed patching time during school hours and to do their homework while patching, and suggested the HRQOL decreased with increased patching time and perhaps time with peers at school. While current studies suggested only 2 h per day of patching or the use of weekend atropine, particularly for those moderate amblyopia.24–26 Thus, unlike the children in our study, most children undergoing patching treatment can accomplish the treatment outside of school hours and at a time when they are not doing homework. This has been shown to be associated with less social stigma15 and potentially minimizes effects on other aspects of HRQOL during amblyopia treatment. HRQOL during the patching treatment accounts for the responses of the child when patched and may not be representative of their overall HRQOL during the treatment. The impact on HRQOL from the perspective of children was variable and could be adapted during amblyopia treatment for school-aged children. The VA of the amblyopic eye and psychosocial expectations about treatment were the main factors that influenced HRQOL during treatment.
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DECLARATION OF INTEREST 16.
This work was financially supported by Wenzhou Technology Bureau, Subject number: Y20100110; Subject number: Y20090019. The authors declare no conflict of interest in the authorship and publication of this contribution.
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strabismus in white and African-American children aged 6 through 71 months: the Baltimore Pediatric Eye Disease Study. Ophthalmology 2009;116:2128–2134. Chia A, Dirani M, Chan YH, Gazzard G, Au Eong KG, Selvaraj P, et al. Prevalence of amblyopia and strabismus in young Singaporean Chinese children. Invest Ophthalmol Vis Sci 2010;51:3411–3417. Pi LH, Chen L, Liu Q, Ke N, Yin ZQ. Prevalence of eye diseases and causes of visual impairment in school-aged Children in western China. J Epidemiol 2012;22:37–44. Multi-Ethnic Pediatric Eye Disease Study (MEPEDS) Group. Prevalence and causes of visual impairment in African-American and Hispanic preschool children: the Multi-Ethnic Pediatric Eye Disease Study. Ophthalmology 2009;116:1990–2000. Pai AS, Rose KA, Leone JF, Sharbini S, Burlutsky G, Varma R, et al. Amblyopia prevalence and risk factors in Australian preschool children. Ophthalmology 2012;119:138–144. Ying GS, Maguire MG, Cyert LA, Ciner E, Quinn GE, Kulp MT, et al. Vision in Preschoolers (VIP) Study Group. Prevalence of vision disorders by racial and ethnic group among children participating in Head Start. Ophthalmology 2014;121:630–636. Sabri K, Knapp KM, Thompson JR, Gottlob I. The VF-14 and psychological impact of amblyopia and strabismus. Invest Ophthalmol Vis Sci 2006;47:4386–4392. Parkes LC. An investigation of the impact of occlusion therapy on children with amblyopia, its effect on their families, and compliance with treatment. Br Orthopt J 2001; 58:30–37. Searle A, Vedhara K, Norman P, Vedhara K. Compliance with eye patching in children and its psychosocial effects: a qualitative application of protection motivation theory. Psychol Health Med 2000;5:43–54. Packwood EA, Cruz OA, Rychwalski PJ, Keech RV. The psychosocial effects of amblyopia study. J AAPOS 1999;3: 15–17. Webber AL, Wood JM, Gole GA, Brown B. Effect of amblyopia on self-esteem in children. Optom Vis Sci 2008; 85:1074–1081. Hrisos S, Clarke MP, Wright CM. The emotional impact of amblyopia treatment in preschool children: randomized controlled trial. Ophthalmology 2004;111:1550–1556. Pediatric Eye Disease Investigator Group. Impact of patch and atropine treatment on the child and family in the amblyopia study. Arch Ophthalmol 2003;121: 1625–1631. Rahi JS, Cumberland PM, Peckham CS. Does amblyopia affect educational, health, and social outcomes? findings from 1958 British birth cohort. BMJ 2006;332:820–825. Felius J, Chandler DL, Holmes JM, Chu RH, Cole SR, Hill M, et al., and Pediatric Eye Disease Investigator Group. Evaluating the burden of amblyopia treatment from the parent and child’s perspective. JAAPOS 2010;14: 389–395. Koklanis K, Abel LA, Aroni R. Psychosocial impact of amblyopia and its treatment: a multidisciplinary study. Clin Exp Ophthalmol 2006;34:743–750. Smith LK, Thompson JR, Woodruff G, Hiscox F. Factors affecting treatment compliance in amblyopia. J Pediatr Ophthalmol Strabismus 1995;32:98–101. Chen X, Yang X, Yu X, Chen Y, Chen J. The development and evaluation of the quality of life scale for amblyopia children with occlusion therapy. J Nurs Sci 2010;25:4–6 (in Chinese). Wen G, McKean-Cowdin R, Varma R, Tarczy-Hornoch K, Cotter SA, Borchert M, et al. General health-related quality of life in preschool children with strabismus or amblyopia. Ophthalmology 2011;118:574–580. Current Eye Research
Impact of Amblyopia Treatment on QOL 7 20. Pediatric Eye Disease Investigator Group. Patching vs Atropine to treat amblyopia in children aged 7 to 12 years: a randomized trial. Arch Ophthalmol 2008;126:1634–1642. 21. Xu J, Lu Q, Huang Y, Yu X. Development and evaluation of Chinese version of the patching treatment questionnaire. Chin Med J 2014;127:1261–1265. 22. Carlton J, Kaltenthaler E. Amblyopia and quality of life, a systematic review. Eye 2011;25:403–413. 23. Birch EE, Cheng CS, Felius J. Validity and reliability of the Children’s Visual Function Questionnaire (CVFQ). J AAPOS 2007;11:473–479. 24. Pediatric Eye Disease Investigator Group. A randomized trial of atropine vs patching for treatment of moderate amblyopia in children. Arch Ophthalmol 2002;120: 268–278.
25. Pediatric Eye Disease Investigator Group. A randomized trial of patching regimens for treatment of moderate amblyopia in children. Arch Ophthalmol 2003;121:603–611. 26. Pediatric Eye Disease Investigator Group. A randomized trial of prescribed patching regimens for treatment of severe amblyopia in children. Ophthalmology 2003;110: 2075–2087. 27. Pediatric Eye Disease Investigator Group Writing Committee. A randomized trial comparing Bangerter filters and patching for the treatment of moderate amblyopia in children. Ophthalmology 2010;117:998–1004. 28. Stewar CE, Fielder AR, Stephens DA, Moseley MJ, MOTAS Cooperative. Treatment of unilateral amblyopia: factors influencing visual outcome. Invest Ophthalmol Vis Sci 2005;46:3152–3160.
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Supplementary material available online Supplementary 1.
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RESEARCH REPORT
Longitudinal Impact on Quality of Life for School-aged Children with Amblyopia Treatment: Perspective from Children Yanyan Chen1, Xinhong Chen1, Jie Chen1, Jingwei Zheng2, Jinling Xu1, and Xinping Yu1 Curr Eye Res Downloaded from informahealthcare.com by Kainan University on 04/28/15 For personal use only.
1
Department of Amblyopia and Strabismus, Eye Hospital of Wenzhou Medical University, Wenzhou, China and 2 Clinical Research Center, Eye Hospital of Wenzhou Medical University, Wenzhou, China
ABSTRACT Background: To evaluate the longitudinal impact on health-related quality of life (HRQOL) during amblyopia treatment for school-aged children from children’s perspective. Methods: School-aged children prescribed amblyopia treatment for the first time were recruited into the current study. Using a questionnaire, subjects’ HRQOL was assessed before patching treatment, and at 8 weeks and 16 weeks after the commencement of patching treatment. Evaluation of visual function and psychosocial aspect was included in the questionnaire. Visual acuity and demographic data of the subjects were recorded. Results: Forty-four children, aged 7–12 years, with anisometropic amblyopia were included in the study. Visual acuity in the amblyopic eye improved 1.90 (0.41–3.74) and 3.98 (2.22–5.11) lines at follow-up weeks 8 and 16, respectively. Both the total score and subscales of the questionnaire were reduced at the first follow-up and recovered at the second follow-up. Scores at week 16 were higher than those before treatment in the psychosocial aspect (p = 0.003), and lower in the visual function aspect (p50.001), without significant difference in total score (p = 0.207). Visual acuity in the amblyopic eye and psychosocial expectations for treatment were the most important factors that influenced HRQOL during treatment. Conclusions: From the children’s perspective, the impacts on visual function and psychosocial aspect were significant in the first two months of treatment, and could be adapted during therapy for school-aged children. More attention should be paid to negative effects of treatment on daily life and study at the stage of amblyopia treatment for school-aged children. Meanwhile, necessary precautions should be taken to help reduce the impacts. Keywords: Amblyopia treatment, health-related quality of life, school-aged child
BACKGROUND
emotional and psychological well-being and selfesteem of children and their families.7–12 Several studies assessed the impact of amblyopia treatment on health related quality of life (HRQOL). For example, the Pediatric Eye Disease Investigator Group (PEDIG) reported that 3–6 year-old children with moderate amblyopia and their parents could tolerate patching treatment during 5 weeks of treatment.13 Sabri et al.7 found that an unpleasant patching experience during childhood could have a negative psychological impact on teenagers. Almost all
Amblyopia is an impairment of best-corrected visual acuity (BCVA) due to the interruption of normal visual development. The prevalence of amblyopia varies from 0.08% to 5.4% of the population among the different races, ethnicities and ages.1–6 The main treatments for amblyopia include correcting refractive error, atropine penalization and patching the sound eye. However, it is increasingly recognized that amblyopia treatment may negatively affect the
Received 25 February 2014; revised 8 December 2014; accepted 18 January 2015; published online 17 March 2015 Yanyan Chen and Xinhong Chen contributed equally to this work. Correspondence: Xinping Yu, Department of Amblyopia and Strabismus, Eye Hospital of Wenzhou Medical University, No. 270, West Xueyuan Rd., Wenzhou 325027, China. Tel: +86 577 88068831. Fax: +86 577 88824115. E-mail: [email protected]
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questionnaires were completed either by the parents of the children under treatment, or by teenagers or adults from their long-term memory.7,13,14 To the best of our knowledge, few HRQOL studies focused on school-aged children undergoing amblyopia treatment from the child’s perspective,11,15,16 as treatment could cause them more negative effects with respect to their daily life and social life. A child’s functional vision decreases to that of the amblyopic eye when the sound eye is covered with an eye patch.17 Study of the longitudinal impact of amblyopia treatment, from beginning to during of the treatment, on school-aged children is limited. We developed a condition-specific questionnaire, and the reliability and validity of the questionnaire were evaluated in our previous study.18 In this study, we investigated the longitudinal impact on HRQOL using the questionnaire for school-aged children during amblyopia treatment.
instructions and without data missing. The two subscales, visual function aspect (6 items) and psychosocial aspect (10 items), were grouped into four principal factors identified through exploratory factor analysis: (1) visual function (6 items); (2) psychosocial impact (6 items); (3) social interaction (2 items) and (4) worries about vision (2 items). We conducted a validation study of the questionnaire and found a cumulative variance of 72.8%. The test–retest reliability (intra-class correlation coefficient, ICC), split-half reliability and Cronbach’s alpha coefficient of the questionnaire were 0.907, 0.907 and 0.883, respectively.18 The items of the questionnaire (Chinese translated into English) are shown in Supplementary 1. Each of the items was scored (0, 25, 50, 75 or 100) according to a 5-point Likert scale, with higher scores (i.e. ‘‘100’’) indicating better HRQOL. For each patient, mean overall score (i.e. the mean of 16 items), mean scores for visual function (6 items) and psychosocial impact (10 items) were calculated.
MATERIALS AND METHODS Ethics statement: The study was approved by the Affiliated Eye Hospital of Wenzhou Medical College Ethics Committee and adhered to the tenets of the Declaration of Helsinki. Recruitment was entirely voluntary, and written informed consent was obtained from the participating children’s parents or their guardians before the study. There was no financial or other form of incentive for the subjects to participate in the study.
About the Questionnaire The questionnaire was designed to provide a method to assess the impact of amblyopia treatment on HRQOL through the perspective of children undergoing amblyopia treatment. The items in the questionnaire were developed on the basis of scientific literature about the impact of amblyopia treatment on HRQOL and clinical experience. The questionnaire initially included 22 items. Several specialists in pediatric eye care, a pediatric psychologist, a statistician and 12 children aged 7–12 years currently receiving with amblyopia treatment and their parents reviewed the initial items for content validity. Eighty-eight children aged 7–12 years undergoing amblyopia treatment, who were recruited in the Strabismus and Amblyopia Department of Eye Hospital of Wenzhou Medical College, completed the questionnaire. The reliability, validity and responsibility of the scale were assessed through dispersion analysis, factor analysis and correlation coefficient. A 16-item questionnaire for children aged 7–12 years with amblyopia treatment was finalized. Children could complete the questionnaire with limited verbal
Longitudinal Impact on Quality of Life for Children with Amblyopia Treatment From March 2009 to October 2009, children were recruited for this study from the Strabismus and Amblyopia Department of the Eye Hospital of Wenzhou Medical College. The eligibility criteria included: (1) children aged 7–12 years, (2) diagnosed with amblyopia for the first time, (3) anisometropic amblyopia, to exclude the effect of strabismus on children’s HRQOL, (4) BCVA of amblyopia eye better than 0.05 in Snellen (1.3 in logMAR), (5) had received no amblyopia treatment before and (6) had no ocular pathology or learning difficulties. The exclusion criteria included: (1) with obvious strabismus (larger than 10 prism diopter, PD), (2) BCVA of amblyopia eye less than 0.05 in Snellen (1.3 in logMAR), (3) with history of ocular surgery and (4) with ocular pathology, such as congenital cataract or glaucoma. All patients had a period of 6 weeks for refractive adaptation to decide the necessity of patching treatment. Patients were then prescribed patching treatment, 4–6 h patching daily (including some time in school), as well as performing near activities for at least 1–2 h during patching. All children were instructed to wear the patch while reading, doing written homework or working on the computer. The parents or guardians recorded the reported patching time per day. BCVA of both the sound eye and the amblyopic eye was recorded before patching treatment, and 8 weeks and 16 weeks after amblyopia treatment with vision chart projector. Functional Visual Acuity (VA) before treatment was defined as VA tested with both eyes open with wearing glasses. Functional VA during Current Eye Research
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Impact of Amblyopia Treatment on QOL 3 treatment was defined as the corrected VA of the amblyopic eye. The questionnaire was completed before patching treatment (with 6 weeks of refractive adaptation) and 8 weeks and 16 weeks after the beginning of amblyopia treatment. At each interview time, the questionnaire was completed in the waiting room before examination. All of the recruited children were asked to complete the questionnaire in the presence of their parents or guardians. Before each interview, the children, their parents or guardians were asked to assess their child’s cooperation in wearing glasses and patching during treatment time. Questionnaires were self-administered with written instructions and were supervised by the same investigator (CXH). If a child did not understand a question, it was read verbatim by CXH without any explanation or elaboration. Inability to respond despite repetition of a question was recorded as ‘‘I don’t know’’. Parents were instructed not to interfere with their child’s responses, and communication (verbal or nonverbal) between child and parent was denied by positioning the parent behind the child.
Statistical Analyses Patients with the who were non-compliant with treatment for the following reasons were excluded from data analysis: glasses wear less than half of waking hours, patching time less than 1.5 h/day and cessation of treatment (spectacle wear or patching) before the planned follow-up time. Analysis of variance of repeatedly measured data was performed to compare HRQOL before and after treatment. Spearman rank correlation analysis was used to investigate the correlation between functional VA and scores of HRQOL. Univariate analyses were performed, including gender and age treated as independent variables. Generalized estimating equation analysis was used to analyze the influence factors for HRQOL during treatment, e.g. the average reported patching time per day. Visual acuity in Snellen was translated to logMAR for statistic analysis. A p 0.05 (two-tailed) was considered statistically significant. No child had ‘‘I don’t know’’ responses for each subscale by the time point. All statistical analyses were performed using software SPSS 12.0 (SPSS, Chicago, IL, USA).
RESULTS Demographic Data of the Subjects Forty-five children were recruited into the study, but one 11-year-old boy with anisometropic amblyopia was excluded from the analysis at the 8th-week !
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TABLE 1 Characteristics of 44 amblyopia children with treatment.
Gender Male Female Age (years)
N
%
21 23 7–12 (8.43 ± 1.34)
48 52
Visual acuity of amblyopic eye (in logMAR) 0.1–0.2 6 0.3–0.7 19 40.7 19
14 43 43
follow-up for uncooperativeness and discontinuation of the patching treatment. Therefore, 44 children were included in the study. Their parents or guardians considered their children to be cooperative, or cooperative most of the time, in the treatment at both follow-up points. Table 1 shows the demographic data of the 44 subjects. Three to eight (4.5 ± 2.7) lines of the interocular difference (IOD) were observed in all of the patients and all had a VA of 0.1 to 0.1logMAR (median, 0 logMAR) in the sound eye. Five patients had a 3.5 to 9.0 D myopic difference and 39 had a 1.5 to 9.0 D (5.0 ± 2.0) hypermetropic difference between the two eyes. With 8 weeks and 16 weeks of patching treatment, VA of the amblyopic eyes improved 1.90 (0.41–3.74) and 3.98 (2.22–5.11) lines, respectively.
HRQOL Changes during Amblyopia Treatment As is shown in Table 2, the scores of both total scale and the two subscales were the lowest at the 8th week of treatment compared to pre-treatment and the 16th week of treatment. At the 16th week, the scores were significantly higher than pre-treatment in the psychosocial aspect (p = 0.003), but remained lower in visual function (p50.001), and no significant differences were found in total scale (p = 0.207; Figure 1).
Association of HRQOL with the Characteristics of Children There was no significant difference between gender (t = 1.96, p = 0.07 at 8 weeks and t = 1.86, p = 0.08 at 16 weeks) and age (t = 0.80, p = 0.43 at 8 weeks and t = 1.84, p = 0.07 at 16 weeks) to the scores of HRQOL. At the 16th week of treatment, children 7 to 5 9 years had better visual function subscales than those aged 9–12 years (p = 0.012). Correlations were statistically significant between functional VA and total HRQOL (r = 0.576, p50.001 at 8 weeks, and r = 0.602, p50.001 at 16 weeks), visual function subscales (r = 0.756, p50.001 at 8 weeks, and r = 0.723,
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TABLE 2 Analysis of variance of repeated measures. Scale scores (x ± S) Domain
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Visual function Psychosocial aspect Total HRQOL
p
Pre-treatment (a)
With treatment 8 weeks (b)
With treatment 16 weeks (c)
F
p
a&b
a&c
b&c
90.06 ± 9.65 79.72 ± 12.64 83.59 ± 9.27
40.53 ± 21.70 67.73 ± 17.93 57.53 ± 14.05
74.91 ± 19.78 84.94 ± 9.59 81.18 ± 11.41
102.437 37.662 105.669
50.001 50.001 50.001
50.001 50.001 50.001
50.001 0.003 0.207
50.001 50.001 50.001
FIGURE 1 Functional visual acuity and HRQOL changes from baseline to 16 weeks.
p50.001at 16 weeks) and psychosocial function (r = 0.246, p = 0.005 at 8 weeks, r = 0.221, p = 0.008 at 16 weeks).
Influence Factors of HRQOL during Amblyopia Treatment Influence factors of HRQOL in amblyopia treatment through generalized estimating equation analysis are shown in Table 3. VA of the amblyopic eye, total QOL scores of pre-treatment and follow-up times (such as 8 weeks and 16 weeks) were the main factors influencing the children’s HRQOL during amblyopia treatment. While the psychosocial scores before treatment and the treatment duration were the main factors affecting the psychosocial aspect during treatment, visual acuity of the amblyopic eye and the treatment duration were the main factors influencing the visual function scores.
DISCUSSION Similar to Sabri et al.,7,19 we found that anisometropic amblyopia impacted children’s HRQOL minimally before treatment. However, HRQOL worsened at the beginning of patching, and recovered with the passage of time and with visual improvement of the amblyopic eye. In general, HRQOL changed with the
improvement in children’s functional vision. In addition, the psychosocial expectation before treatment also had an influence on their social psychology, especially during the first 2 months of treatment. Most studies regarding the impact of amblyopia treatment on HRQOL were based on interviews with children’s parents or guardian, which may not fully reflect the HRQOL condition of children during treatment, particularly in relation to their situation at school or nursery. A more comprehensive investigation from the perspective of children could be performed from different aspects, such as changes in visual function, psychosocial impact and social interaction at school. Study through interviews with parents showed that, during amblyopia treatment, preschool children were happy, cooperative and experienced no problems at nursery.12 Both patching and atropine treatment were well tolerated by 3–6-year-old children.13 However, studies from the perspective of 3–15 years old children revealed more adverse effects of treatment on their social psychology.16 Furthermore, these children had significantly lower self-perception of social acceptance or changes in subjective visual and psychological functions compared with age-matched control subjects.7,11 From the study of PEDIG in 7 to 513 years old children, the social stigma subscale scores on the Parent ATI and Child ATI were poorly correlated, though the overall and adverse effects and treatment compliance subscale scores were moderately to Current Eye Research
Impact of Amblyopia Treatment on QOL 5 TABLE 3 Generalized estimating equation analysis result of influence factors. Domain Total HRQOL
Visual function
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Psychosocial aspect
Factors
Coefficients
Total QOL scores before treatment Age Gender VA of amblyopic eye Patching timea Follow-up timeb Visual function scores before treatment Age Gender VA of amblyopic eye Patching timea Follow-up timeb Psychosocial scores before treatment Age Gender VA of amblyopic eye Patching timea Follow-up timeb
0.565 0.687 3.862 21.899 0.592 23.651 0.077 4.584 0.372 46.354 6.796 34.375 0.603 1.278 3.970 3.260 4.065 17.216
Std. Error 0.100 0.994 2.872 5.182 2.594 2.035 0.139 4.339 1.464 9.174 4.209 3.364 0.093 1.231 3.209 6.139 2.893 2.227
p 50.0001 0.490 0.179 50.0001 0.819 50.0001 0.582 0.291 0.799 50.0001 0.106 50.0001 50.0001 0.299 0.216 0.595 0.160 50.0001
a
Patching time refer to the number of hours patched. Follow-up time refer to the actual time points at which the child was examined.
b
well correlated.15 Therefore, it was necessary to evaluate the HRQOL impact from the perspective of children themselves. We evaluated the longitudinal changes of impact on HRQOL of amblyopia throughout treatment: prepatching and two times point during treatment. Previous studies of the longitudinal impacts did not cover the HRQOL during the treatment.8,10,11,13,15 VA of the amblyopic eye was considered the most important factor affecting the HRQOL of school-aged children undergoing treatment. While the PEDIG study found no difference in HRQOL among children with different levels of baseline VA and VA improvement in the amblyopic eye after 5 weeks of therapy,13 our research rendered different results. The discrepancy might be attributed to differences in interviewing questions, and the age of recruited subjects. The PEGIG study was based on interviews with parents, while the current study was based on the perceptions of children themselves. In addition, PEDIG study enlisted preschool children, while the subjects in this study were all school-aged. It was suggested that preschool children receiving patching treatment are less likely to be self-conscious or feel ashamed than school-aged children.11 In a PEDIG study for 7–12 years old children, the VA in amblyopic eye was improved significant, while the HRQOL reported by parents was similar in 5 weeks and 17 weeks followup.20 It maybe because of impact on HRQOL would be less significant in the PEDIG study than it in our study, for the patching time was 2 h per day in the PEDIG study, and the changes of HRQOL should be less in the PEDIG study with the VA improvement. The questionnaire used in the study was developed specifically for the school-aged children with amblyopia treatment. There are three other questionnaires !
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concerning HRQOL in amblyopia, the ATI (Amblyopia Treatment Index), the A&SQ (Amblyopia and Strabismus Questionnaire) and CVFQ (Children’s Visual Function Questionnaire). While a child version of ATI has been described, which includes treatment difficulty, adverse event and social stigma subscales, the study also described to use the ATI for 7–13 years old children.15 Except in 2014, there was no Chinese version ATI.21 The A&SQ is a useful instrument for assessing overall HRQOL effects of amblyopia and strabismus on adults, but none of the questions in the A&SQ assess the impact of treatment.22 CVFQ has a treatment difficulty subscale and a family impact subscale that can be used to assess the impact of treatment on both children and their family. A previous study reported that patching therapy for patients with unilateral aphakia significantly increased the scores on the treatment difficulty subscale, and suggested that CVFQ was sensitive to changes in treatment,23 whereas the CVFQ is a proxyreported outcome measurement. HRQOL is affected in the first few months of amblyopia treatment. Clinicians and guardians should pay close attention to these children, especially in the early stage of treatment. A previous study suggested that a balance between managing amblyopia and ensuring a child’s psychosocial well-being should be taken into consideration by clinicians and should be included in treatment guidelines.16 Part time patching, atropine penalization and Bangerter treatment would be consideration for the lower burden on children.24–27 There are some limitations to this study. The impact of strabismus upon HRQOL of children may be different from that of amblyopia. Strabismus is significantly associated with worse general HRQOL,
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while no association has been found between amblyopia and the general HRQOL in preschool children.19 Patients with strabismus had higher prevalence of abnormal binocular and eccentric fixation, which were the main factors influencing amblyopia treatment outcome.28 So it will be more difficult for treatment of amblyopia with strabismus in schoolaged children. Children with strabismic amblyopia should be recruited to evaluate the HRQOL impact of amblyopia treatment in future study. In contrast, a longer evaluation term is necessary since the results might not be stabilized with only 16 weeks of followup. Moreover, we did not evaluate the impacts of treatment from the perspective of the children’s family, and we failed to address the treatment difficulty or family impact, which is one of the important concerns during the amblyopia treatment.8,13,15 In further studies, the correlation between both perspectives should be taken into full account. In the study, we instructed the children to include some of the prescribed patching time during school hours and to do their homework while patching, and suggested the HRQOL decreased with increased patching time and perhaps time with peers at school. While current studies suggested only 2 h per day of patching or the use of weekend atropine, particularly for those moderate amblyopia.24–26 Thus, unlike the children in our study, most children undergoing patching treatment can accomplish the treatment outside of school hours and at a time when they are not doing homework. This has been shown to be associated with less social stigma15 and potentially minimizes effects on other aspects of HRQOL during amblyopia treatment. HRQOL during the patching treatment accounts for the responses of the child when patched and may not be representative of their overall HRQOL during the treatment. The impact on HRQOL from the perspective of children was variable and could be adapted during amblyopia treatment for school-aged children. The VA of the amblyopic eye and psychosocial expectations about treatment were the main factors that influenced HRQOL during treatment.
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DECLARATION OF INTEREST 16.
This work was financially supported by Wenzhou Technology Bureau, Subject number: Y20100110; Subject number: Y20090019. The authors declare no conflict of interest in the authorship and publication of this contribution.
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Supplementary material available online Supplementary 1.
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