| BackgroundAge-related macular degeneration(AMD)is a kind of ocular fundus disease with higher age and higher prevalence.At present,our country has entered the age of aging,and the prevalence of AMD is increasing year by year.AMD not only causes visual dysfunction,restricts patients’ daily activities,and causes a decrease in independence,but also seriously affects patients’ mental health,social communication ability and sense of security.Therefore,it is necessary to conduct research on the quality of life assessment of AMD patients,especially the research on the preference-based quality of life,in order to promote the allocation of health resources for AMD.However,at present,there is a lack of clinical application of preference-based measures(PBMs)in AMD populations,especially the lack of comparison data of multiple instruments,which seriously impedes the allocation of health resources for AMD patients in China.ObjectivesAt present,there is no consensus on which PBM performs better in the AMD population.Combining the characteristics of the disease and the current research status at home and abroad,this study includes five PBMs[three generic health-related quality of life(HRQoL)instruments EQ-5D-5L,15D and AQoL-7D;two capability wellbeing instruments ICECAP-A and ICECAP-O]and one eye-disease specific instrument(CLVQoL)among patients with AMD in China.Firstly,PBMs suitable for this population is selected,to provide reference information for health decision-makers in the clinical selection of the scale;and the six quality of life instruments are used to evaluate the survival status from multiple perspectives of AMD patients,in order to assist AMD clinical decision-making,and better organize public health behaviors and meet the challenges AMD brings to society.The specific goals are as follows:1.Based on priori hypotheses,to evaluate and compare the measurement properties of five PBMs,and select the instrument suitable for Chinese AMD patients.2.To measure the quality of life of AMD patients using different types of quality of life instruments.3.To analyze the influencing factors of quality of life instruments scores under different types of AMD patients.4.To explore the relationship between the three preference-based generic HRQoL instruments and two newly preference-based capability wellbeing instruments.MethodsThis study conducted a face-to-face questionnaire survey on AMD inpatients in the Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine between October 2018 and April 2020.The questionnaire mainly includes the individual information and six quality of life instruments(EQ-5D-5L,15D,AQoL-7D,ICECAP-A,ICECAP-O and CLVQoL).The analysis methods and indicators mainly include:1.Convergent validity analysis:Spearman rank correlation analysis and LOWESS curves;2.Known-group validity analysis:non-parametric test(Mann-Whitney U test for two groups,Kruskal-Wallis H tests for more than two groups and Dunn post hoc tests for multiple comparison);3.Sensitivity analysis:ceiling effect,floor effect,effect size(ES),area under the ROC curve and relative efficacy(RE);4.Agreement analysis:Intraclass correlation coefficient(ICC)and Bland-Airman plots;5.Multiple linear regression and exploratory factor analysis(EFA).Results1.Basic condition of the sample populationA total of 215 patients were surveyed,and 5 patients were excluded in the analysis due to missing key information on the scale.The the average age was 71 years old(range50-89).Most patients lived in cities and had a low level of education.Most of the patients started with wet AMD,and the included patients had a wide range of disease courses ranging from 0.1 to 360 months,with a median of 12 months.The visual acuity in the better-seeing eye,the poorer eye and the average visual acuity of both eyes were 0.53±0.51,1.3 1±0.82 and 0.72±0.51.2,respectively.2.Measurement properties evaluation of five PBMs(1)Convergent validity analysis:Moderate to high associations were observed between the CLVQoL and five PBMs(ranged from 0.40 to 0.74),and most of the hypotheses have been verified.In summary,among all five PBMs,the AQoL-7D exhibited the strongest correlations against the CLVQoL.(2)Known-group validity analysis:Except that the ICECAP-O could not distinguish patients with different disease types and the number of affected eyes,the other four PBMs effectively distinguished patients with different disease types,number of affected eyes,and the visual acuity in the better-seeing eye and the hypotheses have been verified.(3)Sensitivity analysis:All PBMs had good sensitivity,but the sensitivity level was still different.Overall,compared with capability wellbeing instruments,the generic HRQoL instruments(especially AQoL-7D)had the better performance in all sub-groups analyses except for the CLVQoL PA dimension.For the CLVQoL PA dimension,the capability wellbeing instruments had better sensitivity(still inferior to AQoL-7D),and ICECAP-O is better than ICECAP-A.(4)Agreement analysis:The pairwise ICCs between any two PBMs(the same type instruments)were all above 0.65 and the B-A plots indicated that there was no pair of PBMs that could be used interchangeably out of the various combinations under comparison.3.The scores of different types of quality of life instruments in the sample population(1)AMD brought significant damage to the patient’s HRQoL,capability wellbeing,and vision-related quality of life(VRQoL).(2)The scores of six quality of life instruments showed almost the same trends in different social demographic information and clinical groups:the older age,lower education level,female(vs male),rural(vs urban),unemploymentor or others(vs employment)and other marital status(vs married),wet/wet(vs wet/dry or vs wet/normal),the longer the course of the disease,bilateral(vs unilateral)and the visual acuity in the better-seeing eye>0.40(vs<0.40),the lower VRQoL/HRQoL/capability wellbeing scores were found.4.Factors affecting the quality of life under different types in the sample population(1)The results of multiple linear regression analysis showed that the influencing factors of different types of instruments were different,but the visual acuity in the better-seeing eye was a common influencing factor.(2)Age(EQ-5D-5L,15D and CLVQoL),gender(15D and AQoL-7D),working status(CLVQoL),residence(ICECAP-A),education level(ICECAP-O),and the visual acuity in the better-seeing eye(EQ-5D-5L,15D,AQoL-7D,ICECAP-A,ICECAP-O and CLVQoL)were the influencing factors of quality of life under different types.5.The relationship between the preference-based generic HRQoL instruments and the capability wellbeing instrumentsIn most cases,the dimensions of the HRQoL instruments and the capability instruments were significantly positively correlated.EFA showed that compared with EQ-5D-5L and 15D,AQoL-7D and capability wellbeing instruments extracted more common factors,and the measurement contents of the two types of instruments had a higher degree of overlap.Conclusions1.Among the five PBMs investigated in this study,based on statistics analysis,the AQoL-7D showed better performance.However,in the context of future studies to be conducted in China,there is a good reason to use the EQ-5D-5L since the instrument also performed better overall and effectively distinguished patients with visual impairments of different severity,and the only existence of a Chinese-specific tariff.Therefore,under certain circumstances,we still recommend EQ-5D-5L is used for Chinese AMD population.2.The quality of life of AMD patients was significantly impaired,and the influencing factors of different types of the quality of life instruments were diversified,but the visual acuity in the better eye was a common significant factor of all instruments.3.Compared with EQ-5D-5L and 15D,AQoL-7D had a higher degree of overlap with the measurement content of the capability wellbeing instruments.It is necessary to further explore the relationship between the two types of PBMs. |