The Development Of A Phase-specific Patient-reported Outcomes Measurement System-Breast Cancer

?Objectives?Patients with breast cancer(BCPs)deal with different core health distresses,among which have not been recognized and intervened in time.This problem deeply influences the quality of life of patients as well as the recovery from the aspects of physical,physiological,and social health.The systematic collection of patient-reported outcomes(PROs)could identify the health distresses of patients so that potentially improve the quality of life of patients and the quality of healthcare.The cores of success of using PROs in researches and clinical settings lie in the selection of contents and measurements of PROs.Patient-reported Outcomes Measurement Information System(PROMIS)is the most advanced,systematic,and standardized PROs measure system.Therefore,based on the current framework and measures of PROMIS,this study focused on postoperative BCPs and BCPs receiving chemotherapy of early stages,and aimed to develop a treatment phase-specific Patient-reported Outcomes Measurement System-Breast(PROMS-B).It would provide a systematic and comprehensive assessment and evaluation system to promote the use of PROs in Chinese BCPs,improve the patients' experience,and eventually benefit the improvement of quality of life and health care.The specific sub-objectives of this study included:1.To define the treatment phase-specific Patient-reported Outcomes Measurement System-Breast Core(PROMS-BC)based on the comprehensive understanding of the core symptoms and treatment impacts of postoperative BCPs and BCPs receiving chemotherapy;2.Based on PROMS-BC,to translate short-forms measuring concepts that have been covered by PROMIS;and develop added treatment phase-specific outcomes measures,thus build up the PROMS-B along with measures translated.3.To test the feasibility,reliability,and validity of PROMS-B.?Methods?The study was comprised of 3 parts.1.The development of PROMS-BC(1)The qualitative study on treatment phase-specific health distresses of BCPsAccording to chronic illness trajectory model,by generic qualitative study,11 postoperative BCPs and 9 BCPs receiving chemotherapy were recruited and interviewed to deeply understand the true experience,core distresses caused by disease and treatments.Based on endpoints model and by summative content analysis,themes and the draft of PROMS-BC were derived from qualitative data.(2)The determination of PROMS-BCBy Delphi expert consultation,12 experts from medical,nursing,PROs,psychology areas were included.The draft of PROMS-BC was revised and optimized according to experts' suggestions and comments,and the final version of PROMS-BC comprising of PROMS-BC-S and PROMS-BC-C was determined.2.The development of PROMS-BBased on PROMS-BC,measures have been covered by PROMIS were identified and translated;measures of added breast cancer specific outcomes were developed.PROMS-B was then produced by combining all measures.(1)The translation and cultural adaptation of PROMIS short-formsFollowing steps of the Functional Assessment of Chronic Illness Therapy Trans(FACIT)methodology,PROMIS short-forms of sleep disturbance,sleep-related impairment,pain,et al were translated.By cognitive interviews of 10 postoperative BCPs and BCPs receiving chemotherapy,cultural adaptation of each short-form was performed.(2)The development of treatment phase-specific breast cancer outcomes measuresGuided by PROs measures development guideline of Food and Drug Administration(FDA),systematic literature review,item evaluation,classification,and screening,cognitive review,and expert review were conducted to build up item banks of self-efficacy,body image,family relationship,and financial burden.According to classic test theory(CTT)and item response theory(IRT),item analysis,item-total correlation,exploratory factor analysis,Cronbach's ? coefficient,and graded response model(GRM)were used to evaluate the measurement property of each item to decide the final inclusion of items.Items failed in meeting 3 or more criteria were considered to be excluded.Short-forms translated and newly developed were integrated as PROMS-B including PROMS-B-Surgery(PROMS-B-S)and PROMS-B-Chemotherapy(PROMS-B-C).3.Measurement examination of PROMS-BBy survey of large sample,187 postoperative BCPs and 246 BCPs receiving chemotherapy were included to complete PROMS-B-S and PROMS-B-C respectively,as well as the Functional Assessment of Cancer Therapy-Breast(FACT-B).Feasibility was presented by effective response rate;reliability was evaluated by Cronbach's ? coefficient and split-half coefficient;construct validity was examined by confirmatory factor analysis(CFA);criterion-related validity was examined by the correlation with FACT-B.?Results?1.The development of PROMS-BC(1)The qualitative study on treatment phase-specific health distresses of BCPsUnrecognized health distresses of postoperative BCPs and BCPs receiving chemotherapy were identified with both commonalities and differences.6 subcategories,14 themes were derived from data of postoperative BCPs;the frequency of ‘the change in sleep time or quality' ranked 1st.16 themes were derived from data of BCPs receiving chemotherapy;the most frequent themes were ‘the change in sleep time or quality' and ‘the over expected out-of-pocket money'.Based on results above,PROMS-BC-S initially contained 15 domains,and PROMS-BC-C contained 18 domains.(2)The determination of PROMS-BCBy two rounds of Delphi expert consultation,13 domains of PROMS-BC-S were determined,among which gastrointestinal symptoms and fatigue were deleted,conjugal relation was revised as family relation.18 domains of PROMS-BC-C were determined,among which itch was deleted,cognitive function was added,and conjugal relation was revised.9 domains in PROMS-BC-S and PROMS-BC-C were the same.PROMS-BC-C added fatigue,gastrointestinal symptoms,cognitive function,ability of participating in social roles and activities,and satisfaction with social roles and activities.New domains compared to PROMIS included body image,family relation,and financial burden.Though self-efficacy and pain were covered by PROMIS,it was necessary to develop or add items according to the characteristics of treatments.2.The development of PROMS-BBy comparing PROMS-BC with PROMIS,13 short-forms of PROMIS were introduced;the PROMIS-Pain short-form was revised;short-forms of self-efficacy and body image(post-operative and chemotherapy),as well as family relation and financial burden were constructed.(1)The translation and cultural adaptation of PROMIS short-formsThe translation team consisting of Chinese and Canadian experts completed the translation of 13 short-forms(74 items),most of which were consistent during the translation process.Wordings and/ or sentence structures were slightly adjusted in 30 items.After cognitive interview,most items(62,83.78%)maintained the original version of translation,the rest of items were modified based on Chinese cultural context.(2)The development of treatment phase-specific breast cancer outcomes measures1)Form the item bankTwenty items were determined for self-efficacy(SE),of which included 12 general items,4 items for post-operation,and 4 items for chemotherapy.19 items were determined for body image(BI),of which included 13 general items,6 items for chemotherapy.27 items were identified for family relation(FR),of which included 5 items for belief consistency,9 for communication and conflict,7 for adaptation,and 6 for parent-child relation.12 items were included for financial burden(FT).2 items were added for pain(post-operation)and pain(chemotherapy)respectively.2)Item inclusionThe CTT-based item evaluation showed that most of the items have good discrimination;The item-dimensions/ total scores correlation coefficients were satisfying except for some items showing strong correlation(r<0.6,P<0.01)with the dimension that was not theoretically belonged to;the factor structures and factor loadings were acceptable while few items showing double factor loadings;Corrected item total correlation of few item was<0.5 and the Cronbach ? coefficient significantly improved after the item deleted.The IRT-based item evaluation suggested that most items performed well in discrimination and difficulty parameter,item characteristic curves(ICC)and scale information functions(SIF)were ideally distributed.SIF of scales ranged from 15.943-59.104.Based on all evaluation indicators above,2 items of SE(post-operation)and SE(chemotherapy)were deleted respectively,1 item of BI(post-operation),3 items of BI(chemotherapy),3 items of FR,1 item of FT were excluded.3.Measurement examination of PROMS-BThe effective response rate of PROMS-B-S was 74.8%.The Cronbach's ? coefficient of each short-form ranged from 0.811 to 0.966,and the half-split reliability were 0.832 to 0.978.CFA results revealed that except upper limb extremity short-form,model fit of each short-form was acceptable,suggesting good structure validity.The absolute value of correlation coefficient of each short-form with FACT-B varied from 0.205 and 0.539(All P<0.01),and the correlation were in accordance with theoretical assumptions,showing good criteria-relation validity.The effective response rate of PROMS-C was 87.9%.The Cronbach's ? coefficients varied from 0.601 and 0.963;however,the Cronbach's ? coefficients of sleep disturbance and belief-consistency dimension of family relation were<0.07.The half-split reliability ranged from 0.768 and 0.985.CFA results showed good model fit of each short-form except physical function short-form.The absolute value of correlation coefficient of each short-form with FACT-B varied from 0.157 to 587(All P<0.01)except values of physical function and ability of participating in social roles and activities short-forms,showing good criteria-relation validity.?Conclusions?1.In general,PROMS-BC covers core health distresses of postoperative BCPs and BCPs receiving chemotherapy,which is of good feasibility and value for patient self-reporting;2.PROMS-B is able to specifically reflect health distresses of postoperative BCPs and BCPs receiving chemotherapy,which helps to identify the physical,psychological and social health status of patients comprehensively.3.PROMS-B is of good feasibility,reliability and validity,which is appropriated to be used to evaluate the health-related outcomes of Chinese BCPs after operation and during chemotherapy.4.The measurement property of PROMIS-upper limb extremity,physical function,ability of participating in social roles and activities short-forms needs to be further examined.