An Item bank to measure impact of refractive error on quality of life Himal Kandel
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Himal Kandel MSc PHEC1, Jyoti Khadka PhD1, Michael Goggin MD2, Konrad Pesudovs PhD1 1NHMRC Centre for Clinical Eye Research, Flinders University, Adelaide, South Australia, 5001, Australia 2University of Adelaide / South Australian Institute of Ophthalmology, Queen Elizabeth Hospital, Adelaide 5011, Australia
Layout
Background • Part of ‘Eye-tem Bank’ project – Develop item banks administered through CAT • Refractive error – Major public eye health problem impacting on people’s quality of life
• Patient reported outcome (PRO): – Shift from ‘Clinician’ to ‘Patient’ driven health care • Essential part of comprehensive outcome assessment • Better understanding of refractive error AND correction impacts • Comparing effectiveness of new/alternative treatment modalities – Eg. SMILE vs LASIK – Different types of soft CL
• Clinical practice, research and policy setting
• Conventional PROs (Paper and pencil based questionnaires) – Questionnaires with fixed set of items (static and inflexible) administered to people with different levels of ability. – Either low range or low precision – High respondent burden • Item banking with Computer adaptive testing (CAT) system – High precision, wider range – Administration of individually tailored items : low respondent burden – Immediate feedback
Objectives • To identify minimally representative, most informative and efficient set of items for an item-bank measuring refractive error-specific quality of life (QoL) • To explore issues important to people with refractive error
Methods
Literature review: Search keywords Condition
Refractive error/s, hyperopia, myopia, astigmatism, presbyopia, near sighted/ness, short sighted/ness, long sighted/ness
Management
Refractive correction, uncorrected Eyeglass/es, glass/es, spectacle/s Contact lens/es, orthokeratology, silicone hodrogel lens, soft contact lens, rigid gas permeable, daily disposable Refractive surgery, refractive surgical procedure/s, kerato-refractive surgery; laser refractive surgery, excimer laser, Keratomileusis Laser In Situ, LASIK, Epi-LASIK, PRK, LASEK, Laser epithelial keratomileusis; Non-laser refractive surgery; radial keratotomy, astigmatic keratotomy, epikeratoplasty, thermokeratoplasty, intrastromal corneal implants , phakic intra-ocular lenses, PRL, phakic intraocular lens implant/s; posterior chamber phakic intraocular lens, multifocal intraocular lens; foldable iris-fixated lens; Artiflex, Implantable contact lens, Lens implant/s, Premium lens implant/s; Inlay/s; intac/s, intracorneal ring segment/s, ICR; RLE, refractive lens exchange , CLE, clear lens exchange, clear lens extraction, PRELEX, presbyopic lens exchange, RLR, refractive lens replacement Patient reported outcome/s, PRO, questionnaire/s, survey, self-report, instrument, measure, Rasch analysis
Instrument & Technique Outcome
Quality of life, vision related quality of life, well-being, satisfaction, self-esteem, emotional, psychological, psychosocial, social, visual performance, activity limitation, visual disability, symptom/s, complication/s, outcome/s, concerns, impact
Qualitative study • QIRC item pool – Items derived from literature search, and professional and lay focus group discussions • In-depth (telephone and face-to-face) interviews with people with refractive error including presbyopia – Audio recorded, transcribed, coded, analyzed – Thematic analysis with deductive and inductive processes, using Nvivo, Version 11
Results
Refractive error-specific PRO instruments used to extract items for the initial item pool (in chronological order) No of items
Basis of original content development
16 41
Not reported Other PROs; expert input
42
Literature review; patient and expert input
15
Other PRO
42
Focus groups with patients
45
Literature review; patient and expert input
24
Literature review; expert input
20
Literature review; patient and expert input
Myopia-specific Quality of Life Questionnaire / Lee Spectacle Survey (ACHIEVE study) / Walline (2006)55 Pediatric refractive error profile (PREP-26) / Walline (2006) 55 Near Vision-related Quality of Life (NVQL) / Patel (2006)56 Contact Lens Impact on Quality of Life (CLIQ) / Pesudovs (2006)12 Visual Function and Quality of Life (VFQoL) / Brady (2010)14 Freedom from Glasses Value Scale(FGVS) / Levy (2010)57 Quality of Vision (QoV) / McAlinden (2010)16
34 37 26 13 28 16 21 30
Other PROs; patient and expert input Not reported Not reported Other PROs Literature review; patient and expert input Other PROs Patient input Literature review; patient and expert input
Refractive error quality of life scale (REQ-Thai) / Sukhawarn (2011)58
87
Other PROs
10
Literature review; expert input
38
Other PROs
Instrument / Author (Year) PERK Study Questionnaire / Bourque (1986) Canadian Refractive Surgery Research Group Quality of Vision Questionnaire (QVQ) / Brunette (2000)7 Refractive status and vision profile (RSVP) / Schein (2000)9 Contact Lens Dry Eye Questionnaire (CLDEQ) / Begley
(2001)52
National Eye Institute Refractive Quality of Life (NEI-RQL) / Berry
(2003)53
Institute for Eye Research Multidimensional Quality of Life for Myopia / Erickson Subjective Vision Questionnaire (SVQ) / Fraenkel
(2004)10
Quality of life Impact of Refractive Correction (QIRC) / Pesudovs
(2004)15
(2005)54
Near activity visual questionnaire (NAVQ) / Buckhurst (2012)17 Student refractive error and eyeglass questionnaire (SREEQ) / Crescioni Total
(2014)13
(2004)11
585
Note: ACHIEVE = Adolescent and Child Health Initiative to Encourage Vision Empowerment; PERK = Prospective Evaluation of Radial Keratotomy
Literature review • No qualitative studies exploring impact of refractive error on adults. – Despite comprehensive patient consultation is essential in constructing high quality PRO instrument • Very few PRO instruments were developed in the developing country settings; all of them have items derived from the PRO instruments developed in the high-income settings. • Similarly, almost all of them are developed for Refractive correction (not for URE)
Interviews – General characteristics of the participants (N = 48) Median age (Min, Max) 49 (22, 76) years Type of refractive correction ¶ Female [n (%)]
28 (58.3)
Type of refractive error:* (n=48)
Glasses
39 (81.3%)
Contact lenses (Soft – daily wear / monthly / annual; Gas permeable;
Myopia [n (%)]
31 (64.6)
Hyperopia [n (%)]
10 (20.8)
Surgical emmetropia [n (%)]
7 (14.6)
Refractive surgery (Laser assisted in-situ
Presbyopia [n (%)]
23 (47.9)
Keratomileusis, Photorefractive
Astigmatism [n (%)]
22 (45.8)
keratectomy, Radial keratotomy)
17 (35.4%)
Orthokeratology)
17 (35.4%)
Interviews – Major findings Theme no
Major themes
Theme 1 Theme 2
People with refractive error are worried about their condition. People with refractive error have difficulty doing physical, recreational and day-to-day activities. People with refractive error are bothered by the inconveniences they have to live with. People with refractive error live with unwanted ocular and nonocular sensations. Refractive error affects people’s psycho-social well-being.
Theme 3 Theme 4 Theme 5 Theme 6
Refractive error has huge economic implications in people’s lives.
Number of coded segments 769 471 326 319 305 177
Sub-themes contributing to the major themes
Source of items A. Extant items a. Refractive error-specific patient reported outcome instruments
No of items 700 498
b. Grey literature
202
B. Qualitative Studies a. Interviews b. Quality of life Impact of Refractive Correction item pool
1184 807 377
Total
1884
Item classification and selection
• Binning • Systematically grouping items by their meaning and the latent trait they measure • Winnowing • Reduction of large number of items into a representative set • Systematic item deletion criteria: Redundancy, Clarity, Applicability, Frequency, Relevance • Cognitive interviews • Comprehension, Interpretation, Clarity and common language usage AL
MB
VS
OS
GS
HC
Initial item pool
422
64
131
97
32
Final Item pool
80
19
27
16
10
CV
EM
SC
EC
479 219
192
60
111 77
1884
41
53
16
18
337
44
Coping Total 13
Note: AL = Activity limitation, MB = Mobility, VS = Visual symptoms, OS = Ocular-comfort symptoms, GS = General symptoms, HC = Health concerns, CV = Convenience, EM = Emotional well-being, SC = Social well-being, EC = Economic well-being
Sources of unique items 100%
80
19
27
16
10
41
44
53
16
18
13
90% 80% 70% 60% 50% 40% 30% 20% 10% 0% AL
MB
VS
OS
Only qualitative
GS
HC
Common
CV
EM
SC
Only literature
EC
Coping
Note: AL = Activity limitation, MB = Mobility, VS = Visual symptoms, OS = Ocular-comfort symptoms, GS = General symptoms, HC = Health concerns, CV = Convenience, EM = Emotional well-being, SC = Social well-being, EC = Economic well-being
Comparison of RE-Bank with other ophthalmic item-banks VS
OS
GS
AL
MB SC
EM EC
CV
HC
RE - Total RE-New AMD* Glaucoma* DR* HRD* ARD*
27 8 11 13 10 16 14
16 2 8 12 6 4 6
10 3 0 6 1 3 2
80 11 59 49 55 51 42
19 2 12 14 13 13 8
16 2 10 11 10 9 7
53 13 24 26 25 24 24
18 5 9 12 5 7 5
44 37 6 5 6 5 3
41 20 19 16 14 13 11
Copi ng 13 4 0 0 0 9 5
Overlap with all modules
6
2
0
25
2
2
12
3
1
7
0
Total 337 107 (32%) 158 (49%) 164 (48%) 145 (45%) 154 (45%) 127 (43%) 60 (19%)
Note: AL = Activity limitation, MB = Mobility, VS = Visual symptoms, OS = Ocular-comfort symptoms, GS = General symptoms, HC = Health concerns, CV = Convenience, EM = Emotional well-being, SC = Social well-being, EC = Economic well-being
Conclusion • Content for refractive error specific item bank identified – 337 items across 11 domains • The most important phase of the item-bank development process. • Qualitative study findings: – Important issues for people with refractive correction: Concerns about cosmetic appearance with glasses, personal health and safety, difficulties in day-to-day activities, and inconveniences rendered in daily life – Refractive correction not always addresses quality of life issues; many a times add issues.
Way forward … • The survived items will be pilot-tested in large number of participants across the diverse spectrum of refractive error. • Assessment of psychometric properties, validity and reliability will be done using both classical test theory and Rasch analysis. • Item bank administered through CAT system will be superior to the currently existing paper and pencil based PRO instruments. • Similar exercise is being carried out in the developing country setting (Nepal), including uncorrected refractive error.
Thank you!
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