The Development And Utilization Of Patient-Reported Outcome In Psoriasis

BackgroundPsoriasis is a chronic,autoimmune,systemic inflammatory disorder,characterized as skin plaques.Traditional clinical assessments depend on objective indicators,which is easy to lose sight of patients’ internal expectation and subjective feeling for health status during the medical process.This issue is very prominent in chronic diseases management and treatment,such as psoriasis.Along with the transition of the modern medical model from the biomedical model into the socio-bio-psychomedical model,patient-centered philosophy has been emphasized,more and more attention has been paid to patient-reported outcome(PRO),a new clinical outcome.PRO,independent of medical intervention,is patients’ subjective evaluation in of severity of illness,health-related quality of life(HRQo L),treatment satisfaction and compliance.The PRO provides subjective assessment of health of illness status and new train of thought in therapeutic area,especially in pruritus,pain and appearance improvement.Currently,the HRQo L scales used in psoriasis domain are basically derived from western countries,domestic related-research started late.Independently developed Chinese PRO scales most based on the theory of traditional Chinese medicine and hasn’t gain a wide range of usage,which may not reflect the characteristics of Chinese patients with psoriasis during the treatment.According to the above concept,this study aims to establish a psoriasis PRO scale with Chinese characteristicsBesides,chronic diseases,such as psoriasis,increase social and financial burden for healthcare system significantly.The prevention and cure for chronic diseases consumed a lot of medical and health resources,great importance should be attached to this situation.Over the last decades,a research method named willingness-to-pay(WTP)has been widely used in health care policy decisions.At present,the application of WTP in psoriasis domain stayed in primary stage.There is no relevant WTP-related research in China.This study also aims to preliminary explore the WTP usage in psoriasis under Chinese background.Objectives(1)The purpose of this study is to develop a PRO scale of psoriasis based on the production principles and process set by American Food and Drug Administration.The 4 dimensions of the PRO scale aims to investigate the status of the physical,mental,social support and treatment attitude and the related-influencing factors in patients with psoriasis in Changsha.(2)The purpose of this study is to preliminarily explore the 2kinds of WTP application in psoriasis domain.The willingness of the patients with psoriasis and related-influencing factors are going to be analyzed.Methods(1)The literature review,panel discussion and qualitative interview were used to initially develop the item pool of PRO scale of psoriasis.Delphi method was used to revise and adjust the dimensions and the items of the PRO scale,and form the initial PRO scale.Items analysis of the initial PRO scale was assessed by critical value method and correlation coefficient method.Internal consistency and reliability were assessed using Cronbach’s alpha coefficient and Guttman split-half coefficient.Validity was assessed using content validity and construct validity.Finally,the unified screening of the PRO scale items was determined by critical value method,discrete trends method,correlation coefficient method Cronbach’s alpha coefficient and factor analysis.(2)The psoriasis PRO scale was used to measure the status physical,mental,social support and treatment.The general information was collected by Xiangya Skin Disease Dataset.The disease severity was assessed by 4 clinical measure indicators,including Psoriasis Area and Severity Index(PASI),Body Surface Area(BSA),Physician’s Global Assessment(PGA)and Dermatology Life Quality Index(DLQI).Univariate analysis and multiple linear regression were used to analyze the status of physical,mental,social support,treatment and related influencing factors.Pearson’s correlation analysis was used to analyze the PRO scores and the clinical measure indicators.(3)The WTP questionnaire was used to investigate the willingness for optimal therapeutic schedule.The general information was collected by Xiangya Skin Disease Dataset.The disease severity was assessed by PASI,BSA,PGA and DLQI.Univariate analysis and multiple linear regression were used to analyze the WTP in the form of total expenditure and percentage of monthly income,and related influencing factors.Results(1)After item analysis,validity analysis,reliability analysis and item screening,the PRO the psoriasis was constructed.The PRO scale has 4domains,including physical(9 items),mental(14 items),social support(8items)and treatment(10 items),and 41 items.Cronbach’s ? coefficient of total scale was 0.868,Cronbach’s ? coefficient of subscales ranged from0.560 to 0.921.Guttman split-half coefficient of total scale was 0.742,Guttman split-half coefficient of subscales ranged from 0.603 to 0.883.The confirmatory factor analysis showed,factor loading of items ranged from0.43 to 0.90,except for certain items.(2)The most affected physical domain items are desquamation,dryness and pruritus.Multiple linear regression analysis showed that the influencing factors of physical domain are psoriasis types(b=-1.156,P=0.010),lesions involving genital(b=2.765,P(27)0.001)and disease duration(b=2.182,P(27)0.001).Patients who have special types of psoriasis,lesions involving genital and longer disease duration had higher physical subscales scores and higher damage in physical health.(3)The most affected mental domain items are being afraid of illness aggravation and being worry about the relapse.Multiple linear regression analysis showed that the influencing factors of mental domain are education level(b=-1.785,P(27)0.001),lesions involving genital(b=4.673,P(27)0.001)and disease duration(b=4.673,P(27)0.001).Patients who have lower education level,lesions involving genital and longer disease duration had higher mental subscales scores and higher damage in mental health.(4)The most affected social support domain items are being considered as infectious,being worried for heredity,and the initiative to exchange condition with relatives or friends.Multiple linear regression analysis showed that the influencing factors of social support domain are smoking(b=0.639,P=0.014),habitation(b=0.639,P=0.014)and disease duration(b=0.639,P=0.014).Patients who smoke,live in the city and have longer disease duration had higher social support subscales scores and received lower level of social support.(5)The most affected treatment domain items in treated patients are having difficulty in the adherence to treatment,forgetting to use medicine under exceptional conditions,and had been forgot to use medicine in the past two weeks.Multiple linear regression analysis showed that the influencing factors of treatment domain are smoking(b=0.639,P=0.014)and abdominal obesity(b=0.639,P=0.014).The patients who smoke and have abdominal obesity had higher treatment subscales scores and more passive attitude towards correct treatment behavior.(6)Pearson’s correlation analysis showed the total scores of PRO have low-to-moderate correlation with PASI,BSA,PGA and DLQI scores.(7)As for ideal cure for psoriasis,the median of WTP-per(WTPpercentage of monthly income)was 20.0%(Q1,10.0%;Q3 40.0%),mean WTP-total was 26.56%?20.17%.Multiple linear regression analysis showed that the influencing factors of patients’ WTP-per was marriage(b=11.506,P(27)0.001)and previous medical expenditure(b=5.001,P=0.024).(8)As for ideal cure for psoriasis,the median of WTP-total(WTPtotal payment)was 10 thousand CNY(Q1,5 thousand CNY;Q3,30 thousand CNY),mean WTP-total was 34.1?88.3 thousand CNY.Multiple linear regression analysis showed that the influencing factors of patients’ lg(WTP-total)was marriage(b=0.260,P=0.005),education level(b=0.137,P=0.032),disease duration(b=0.184,P=0.003),DLQI(b=-0.173,P=0.005)and previous medical expenditure(b=0.168,P=0.006).Conclusions(1)The PRO scale for psoriasis constructed in this study includes physical scale(9 items),mental scale(14 items),social support scale(8items)and treatment scale(10 items),with a total of 4 subscales and 41 items.The PRO scale with moderate numbers of items conforms to the theory.The reliability and validity have been confirmed.The PRO scale for psoriasis can be used as an assessment tool to evaluate psoriatic patients’ physical,mental,social support and treatment status.(2)Psoriatic patients’ physical,mental,social support and treatment status were affected by varying degree.The patients with special types of psoriasis,lesions involving genital and long disease duration had higher levels of physical damage.The patients who have lower education level,lesions involving genital and longer disease duration had higher levels of mental damage.The patients who smoke,live in the city and have longer disease duration had lower levels of social support.The patients who smoke and have abdominal obesity had more passive attitude towards correct treatment behavior.(3)The patients with psoriasis showed positive willingness to the ideal cure.The patients who have higher education level,longer disease duration,lower DLQI,higher previous medical expenditure in psoriasis and without spouse,showed higher WTP-total.The patients who have higher previous medical expenditure in psoriasis and without spouse,showed higher WTP-per.