-
Je něco špatně v tomto záznamu ?
Psychometric evaluation of the near activity visual questionnaire presbyopia (NAVQ-P) and additional patient-reported outcome items
J. Sims, B. Sloesen, S. Bentley, C. Naujoks, R. Arbuckle, S. Chiva-Razavi, B. Pascoe, J. Stochl, A. Findley, P. O'Brien, JS. Wolffsohn
Jazyk angličtina Země Německo
Typ dokumentu časopisecké články
Grantová podpora
Novartis Pharma
Novartis Pharma
NLK
Directory of Open Access Journals
od 2017
PubMed Central
od 2017
Europe PubMed Central
od 2017
ProQuest Central
od 2018-12-01
Nursing & Allied Health Database (ProQuest)
od 2018-12-01
ROAD: Directory of Open Access Scholarly Resources
od 2017
Springer Journals Complete - Open Access
od 2017-12-01
Springer Nature OA/Free Journals
od 2017-12-01
- MeSH
- dospělí MeSH
- hodnocení výsledků péče pacientem MeSH
- lidé MeSH
- myopie * MeSH
- presbyopie * diagnóza MeSH
- psychometrie MeSH
- reprodukovatelnost výsledků MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- Geografické názvy
- Austrálie MeSH
BACKGROUND: The Near Visual Acuity Questionnaire Presbyopia (NAVQ-P) is a patient-reported outcome (PRO) measure that was developed in a phakic presbyopia population to assess near vision function impacts. The study refined and explored the psychometric properties and score interpretability of the NAVQ-P and additional PRO items assessing near vision correction independence (NVCI), near vision satisfaction (NVS), and near vision correction preference (NVCP). METHODS: This was a psychometric validation study conducted using PRO data collected as part of a Phase IIb clinical trial (CUN8R44 A2202) consisting of 235 randomized adults with presbyopia from the US, Japan, Australia, and Canada. Data collected at baseline, week 2, and months 1, 2, and 3 during the 3-month trial treatment period were included in the analyses to assess item (question) properties, NAVQ-P dimensionality and scoring, reliability, validity, and score interpretation. RESULTS: Item responses were distributed across the full response scale for most NAVQ-P and additional PRO items. Confirmatory factor analysis supported the pre-defined unidimensional structure and calculation of a NAVQ-P total score as a measure of near vision function. Item deletion informed by item response distributions, dimensionality analyses, item response theory, and previous qualitative findings, including clinical input, supported retention of 14 NAVQ-P items. The 14-item NAVQ-P total score had excellent internal consistency (α = 0.979) and high test-retest reliability (Intraclass Correlation Coefficients > = 0.898). There was good evidence of construct-related validity for all PROs supported by strong correlations with concurrent measures. Excellent results for known-groups validity and ability to detect change analyses were also demonstrated. Anchor-based and distribution-based methods supported interpretation of scores through generation of group-level and within-individual estimates of meaningful change thresholds. A meaningful within-patient change in the range of 8-15-point improvement on the NAVQ-P total score (score range 0-42) was recommended, including a more specific responder definition of 10-point improvement. CONCLUSIONS: The NAVQ-P, NVCI, and NVS are valid and reliable instruments which have the ability to detect change over time. Findings strongly support the use of these measures as outcome assessments in clinical/research studies and in clinical practice in the presbyopia population.
Adelphi Values Patient Centered Outcomes Bollington UK
Charles University Prague Czechia
Novartis Pharma AG Basel Switzerland
School of Optometry College of Health and Life Sciences Aston University Birmingham UK
- 000
- 00000naa a2200000 a 4500
- 001
- bmc24014347
- 003
- CZ-PrNML
- 005
- 20240905134423.0
- 007
- ta
- 008
- 240725s2024 gw f 000 0|eng||
- 009
- AR
- 024 7_
- $a 10.1186/s41687-024-00717-9 $2 doi
- 035 __
- $a (PubMed)38592339
- 040 __
- $a ABA008 $b cze $d ABA008 $e AACR2
- 041 0_
- $a eng
- 044 __
- $a gw
- 100 1_
- $a Sims, Joel $u Adelphi Values, Patient-Centered Outcomes, Bollington, UK. joel.sims@adelphivalues.com $1 https://orcid.org/0000000304742186
- 245 10
- $a Psychometric evaluation of the near activity visual questionnaire presbyopia (NAVQ-P) and additional patient-reported outcome items / $c J. Sims, B. Sloesen, S. Bentley, C. Naujoks, R. Arbuckle, S. Chiva-Razavi, B. Pascoe, J. Stochl, A. Findley, P. O'Brien, JS. Wolffsohn
- 520 9_
- $a BACKGROUND: The Near Visual Acuity Questionnaire Presbyopia (NAVQ-P) is a patient-reported outcome (PRO) measure that was developed in a phakic presbyopia population to assess near vision function impacts. The study refined and explored the psychometric properties and score interpretability of the NAVQ-P and additional PRO items assessing near vision correction independence (NVCI), near vision satisfaction (NVS), and near vision correction preference (NVCP). METHODS: This was a psychometric validation study conducted using PRO data collected as part of a Phase IIb clinical trial (CUN8R44 A2202) consisting of 235 randomized adults with presbyopia from the US, Japan, Australia, and Canada. Data collected at baseline, week 2, and months 1, 2, and 3 during the 3-month trial treatment period were included in the analyses to assess item (question) properties, NAVQ-P dimensionality and scoring, reliability, validity, and score interpretation. RESULTS: Item responses were distributed across the full response scale for most NAVQ-P and additional PRO items. Confirmatory factor analysis supported the pre-defined unidimensional structure and calculation of a NAVQ-P total score as a measure of near vision function. Item deletion informed by item response distributions, dimensionality analyses, item response theory, and previous qualitative findings, including clinical input, supported retention of 14 NAVQ-P items. The 14-item NAVQ-P total score had excellent internal consistency (α = 0.979) and high test-retest reliability (Intraclass Correlation Coefficients > = 0.898). There was good evidence of construct-related validity for all PROs supported by strong correlations with concurrent measures. Excellent results for known-groups validity and ability to detect change analyses were also demonstrated. Anchor-based and distribution-based methods supported interpretation of scores through generation of group-level and within-individual estimates of meaningful change thresholds. A meaningful within-patient change in the range of 8-15-point improvement on the NAVQ-P total score (score range 0-42) was recommended, including a more specific responder definition of 10-point improvement. CONCLUSIONS: The NAVQ-P, NVCI, and NVS are valid and reliable instruments which have the ability to detect change over time. Findings strongly support the use of these measures as outcome assessments in clinical/research studies and in clinical practice in the presbyopia population.
- 650 _2
- $a dospělí $7 D000328
- 650 _2
- $a lidé $7 D006801
- 650 12
- $a myopie $7 D009216
- 650 _2
- $a hodnocení výsledků péče pacientem $7 D000071066
- 650 12
- $a presbyopie $x diagnóza $7 D011305
- 650 _2
- $a psychometrie $7 D011594
- 650 _2
- $a reprodukovatelnost výsledků $7 D015203
- 651 _2
- $a Austrálie $7 D001315
- 655 _2
- $a časopisecké články $7 D016428
- 700 1_
- $a Sloesen, Brigitte $u Novartis Pharma AG, Basel, Switzerland
- 700 1_
- $a Bentley, Sarah $u Adelphi Values, Patient-Centered Outcomes, Bollington, UK
- 700 1_
- $a Naujoks, Christel $u Novartis Pharma AG, Basel, Switzerland
- 700 1_
- $a Arbuckle, Rob $u Adelphi Values, Patient-Centered Outcomes, Bollington, UK
- 700 1_
- $a Chiva-Razavi, Sima $u Novartis Pharma AG, Basel, Switzerland
- 700 1_
- $a Pascoe, Ben $u Adelphi Values, Patient-Centered Outcomes, Bollington, UK
- 700 1_
- $a Stochl, Jan $u Adelphi Values, Patient-Centered Outcomes, Bollington, UK $u Charles University, Prague, Czechia
- 700 1_
- $a Findley, Amy $u Adelphi Values, Patient-Centered Outcomes, Bollington, UK
- 700 1_
- $a O'Brien, Paul $u Novartis Pharma AG, Basel, Switzerland
- 700 1_
- $a Wolffsohn, James S $u School of Optometry, College of Health and Life Sciences, Aston University, Birmingham, UK
- 773 0_
- $w MED00215150 $t Journal of patient-reported outcomes $x 2509-8020 $g Roč. 8, č. 1 (2024), s. 41
- 856 41
- $u https://pubmed.ncbi.nlm.nih.gov/38592339 $y Pubmed
- 910 __
- $a ABA008 $b sig $c sign $y - $z 0
- 990 __
- $a 20240725 $b ABA008
- 991 __
- $a 20240905134417 $b ABA008
- 999 __
- $a ok $b bmc $g 2143867 $s 1226213
- BAS __
- $a 3
- BAS __
- $a PreBMC-MEDLINE
- BMC __
- $a 2024 $b 8 $c 1 $d 41 $e 20240409 $i 2509-8020 $m Journal of patient-reported outcomes $n J Patient Rep Outcomes $x MED00215150
- GRA __
- $a Novartis Pharma $p Novartis Pharma
- LZP __
- $a Pubmed-20240725