Research On The Development And Measurement Properties Assessment Of People Living With HIV/AIDS (PLWHA) Patient Report Outcome Assessment Scale

Objective: This study will conduct a systematic review of the existing Patient-reported Outcomes(PRO)scales for AIDS-specific patients and summarize all scales.The COSMIN guidelines and the COSMIN risk of bias checklist will be used to assess the methodological quality and performance and other aspects of all scales.and the advantages and disadvantages of each scale are compared.We will use a combination of qualitative and quantitative methods to develop,revise and verify the PLWHA Patient Report Outcomes Assessment Scale(PLWHA-PRO),which provides an effective tool for the evaluation of AIDS patient report outcomes in China.We use self-made questionnaires and PLWHA-PRO scale to conduct questionnaire surveys among the PLWHA population in China to explore the determinants factors that affect the PRO of PLWHA,and provide a reference and suggestion for the targeted improvement of the PRO of the PLWHA population and better development of AIDS prevention and control work.Methods: This study conducted a systematic review of the existing AIDS disease-specific PRO scale based on the COSMIN guidelines and the PRISMA.On August 29,2019,a search was conducted on three literature databases: MEDLINE(via Pubmed),Embase,and Psyc INFO to search for the AIDS-related PRO scale.Two researchers independently carried out deduplication,screening,verification,data extraction,methodological quality evaluation and measurement properties evaluation.The methodological quality and performance evaluation utilizes the COSMIN guidelines and the COSMIN risk of bias checklist.We summarize the existing scales based on the results of the systematic review,sort the items to build an item pool,and build a patient-centered theoretical conceptual framework.Based on the theoretical conceptual framework,the items are revised,filtered and optimized to simplify the item pool.Then,through expert item review and patient focus group interviews,the items in the first version of the scale were analyzed qualitatively,and the PLWHA-PRO scale was compiled.The self-made scale was used to investigate 700 PLWHA in four cities in China(Huludao City from Liaoning Province,Zhengzhou City from Henan Province,Taizhou City from Zhejiang Province,and Fuyang City from Anhui Province).The PLWHA-PRO scale was analyzed for discrete trend,internal consistency,split-half reliability,test-retest reliability,structure validity,convergent validity and discriminative validity,known groups validity,item response theory grade response model and other performance evaluation,the feasibility,reliability,validity and discrimination of the first version of the scale are evaluated,and the final version of the scale is formed.Using the final version of the scale to survey 450 PLWHA in three cities in China(Huludao City from Liaoning Province,Zhengzhou City from Henan Province,and Taizhou City from Zhejiang Province),by describing the general characteristics and PRO status of the PLWHA population and analyzing the determinants factors of its PRO from demographic characteristics,health behaviors Information,health information,and virus infection status.The independent sample t-test or ANOVA was used to compare PRO scores.On the basis of univariate analysis,variables related to PRO found in univariate analysis were used as independent variables for multiple linear regression analysis.Results:(1)A total of 10325 articles were researched in 3 databases.According to the inclusion and exclusion criteria of the literature,a total of 147 literatures(150 records)were finally included.These literatures included a total of 87 related PRO scales in 8 categories.And follow the COSMIN guidelines to systematically evaluate the psychometric properties of these scales and the methodological quality of the research.In the included scales,the ratings are poor in terms of content validity,cross-cultural validity and test-retest reliability.In addition,the existing research largely ignores the evaluation of measurement error and responsiveness.Based on the COSMIN guidelines and the results of the GRADE method,the research team recommends the use of 9 scales including Poz Qol,SSC-HIV,HSS-30,IHIV,PLHIV-RS,HIV-MT-SES,HECCS,HIV-ASES,HIVSMS-W.(2)According to the results of the systematic review,a total of 50 PRO scales for AIDS-specific patients were included,and all the dimensions of the included scales were further summarized and classified.Based on the summary results of dimensions,a preliminary theoretical conceptual model including 10 first-level indicators and 41 secondlevel indicators was determined.A new theoretical conceptual model including 8 first-level indicators and 38 second-level indicators was obtained through Delphi expert consultation.According to the theoretical conceptual model and the results of the systematic review,an item pool was constructed and preliminary screening of items was carried out.The initially constructed item pool included 350 items.Then,through expert consultation and assessment of items,a new item pool containing 108 items was finally obtained,and the first version of the PLWHA-PRO was compiled.Finally,through patient focus group interviews,the item description was optimized to form the final version of the PLWHAPRO.(3)The PLWHA-PRO scale was used to survey 700 PLWHA in four cities in China,and 598 valid questionnaires were collected.The degree of dispersion is measured according to the standard deviation of the scores of each item.It is recommended to delete 38 items with a standard deviation less than 0.96.The internal consistency Cronbach’s α coefficient of each dimension of the scale is greater than 0.7,indicating that the internal consistency reliability of the scale is very good.By calculating the Cronbach’s α coefficient of each dimension after deleting the entry,it is recommended to delete 7 items.In addition to the Global health dimension and the Treatment dimension,the Guttman Split-Half coefficients of the total scale and other dimensions are all greater than 0.7,indicating that the split-half reliability of the scale is good.By comparing the correlation between the first measurement results of 50 PLWHA and the retest results two weeks later,the correlation coefficients were all greater than 0.7,and there was no difference between the average scores of the two measurements.From the perspective of the compilation process,the research methods and procedures of this scale are standardized,the content of the scale is set reasonably,and it has good content validity.The KMO statistic result of the exploratory factor analysis is 0.970,and the Bartlett sphericity test P=0.000,which means it is suitable for factor analysis.The principal component maximum variance rotation method is adopted.The number of factors is determined by the feature value greater than 1,and the factor load greater than 0.4 as a condition for the entry to be selected as a factor.As a result,a total of 13 common factors are obtained,with a cumulative variance contribution rate of70.375%,and items are deleted with small load(<0.4)on each factor and indexes with similar load coefficients on two or more factors without specificity,14 items are recommended to be deleted through this method.The correlation coefficients of the dimensions of PLWHA-PRO and the corresponding dimensions of the PROQOL-HIV scale are all greater than 0.4,indicating that the scale has good correlation validity.The correlation coefficient between each item of the scale and its dimension is greater than 0.4,indicating that the convergent validity is better,and the correlation between each item of the scale and its dimension is higher than that of other dimensions,indicating that these items have good discriminative validity.A total of 11 items are recommended to be deleted after the evaluation of the convergent validity and the discriminative validity.The knowngroup validity test was performed on the subgroups of participants through patient status(P=0.048),CD4+ T cell count(P=0.004)and viral load(P=0.361).The results show that the known-group validity of the scale is good.The results of the item response theory GRM model of the scale show that items with a discrimination parameter less than 0.8 or a difficulty level parameter other than-3 to 3 should be eliminated.The unsatisfactory ICC curve distribution should also be eliminated.According to the results of IRT,it is recommended to delete 11 items.According to the performance evaluation results,the final version of the scale containing 48 items in 8 dimensions is finally obtained.(4)We used self-made questionnaires and scales to conduct a survey among 450 PLWHAs in three cities in China,and retrieved 402 valid questionnaires.The average age of the subjects was 37.87±12.11 years(19-78),of which 18.4% were elderly.The majority were males(84.6%),married 40.5%,junior high school education accounted for 26.4%,most subjects did not participate in physical exercise(34.8%)and recreational activities(50.7%),the average length of illness was 4.44±3.49 years(0-20),The majority of participants(64.7%)believed that the way they were infected with HIV was homosexual sex,96.3% of the study subjects are now receiving antiviral treatment.The Cronbach’s α coefficient of the PLWHA-PRO scale is 0.979,the Cronbach’s α coefficient of all dimensions are also greater than 0.7,and the total PRO score of PLWHA is 181.20±39.03.The results of the univariate analysis show that gender,registered residence form,education,family monthly income per capita,occupation,smoking,drinking,number of physical exercises per week,sexual orientation,openness of sexual orientation,whether the sleeping condition is good,whether you have received psychological counseling,the infection route you think and whether there are other opportunistic infections are the determinants that affects the PRO total score of PLWHA(P<0.05).The results of multiple linear regression analysis showed that gender,registered residence form,occupation,smoking,number of physical exercises per week,whether the sleeping condition is good,whether you have received psychological counseling,the infection route you think,and whether there are other opportunistic infections are the main determinants of PLWHA’s PRO total score.Conclusion:(1)According to the results of the systematic review of 87 included HIVspecific PRO scales,Poz Qol,SSC-HIV,HSS-30,IHIV,PLHIV-RS,HIV-MT-SES,HECCS,HIV-ASES,HIV-SMS-W scales perform well in performance evaluations such as methodological quality,reliability and validity.(2)Through scientific and complete scale development and performance evaluation,finally,a scale containing 48 items in 8 dimensions including Global health,Symptoms,Physical function,Cognitive function,Mental health,Worry and distress,Social function and Treatment was selected.The scale will become an effective evaluation tool for China’s AIDS PRO measurement.(3)Factors such as gender,registered residence form,occupation,smoking,number of physical exercises per week,whether the sleeping condition is good,whether you have received psychological counseling,the infection route you think,and whether there are other opportunistic infections and other factors have an impact on the PRO status of China’s PLWHA.