Development Of The Patient Reported Outcomes Instrument For Acute Leukemia

Objectives:The purpose of the study was to develop an instrument to measure the clinical outcomes reported from patients with acute leukemia.Methods:The study included five stages and was conducted based on Roger's whole person theory and under the guidance for developing Patient-Reported Outcome Measures released by U.S.Department of Health and Human Services:(1)To establish preconceived conceptual framework and items of scale through lots of literature survey,retrospective clinical case and deep instrument analyses;(2)For the item-generation phase,27 patients with acute leukemia were semi-structure interviewed under the instruction of the conceptual framework of the scale,and the results were obtained to extract items.(3)The items were preliminary screened by means of “storage” and “selection" methods,then the conceptual framework of pretest was adjusted by expert consultation and clinical pre-investigation.(4)25 experts who work in clinical nursing,social psychology and scale development were enrolled in two-round Delphi method.According to the result of the consultation,we adjust conceptual framework and items pool of the scale.Finally the ALPRO pretesting scale reporting 4 clinical outcomes of Physical,Psychological,Social,and Treatment satisfaction was established.(5)For the validation phase,a total of 406 patients with acute leukemia were selected for the evaluation of the project analysis and validity test of the pre-test scale,and the ALPRO formalized scale was formed.Results:Item screening produce 116 items and 100 were kept after experts consultation and preliminary investigation,30 items were deleted through two rounds of two-round Delphi method.Finally the ALPRO pretesting scale contains 70 items.Project analysis phase remove 11 items,keeping 59 items for exploratory factor analysis in their own areas.Physiological field consists of 15 items,producing 3 common factors,which are named as disease symptoms,treatment of toxic and side effects,daily life ability,and the cumulative variance contribution rate is 67.618%.Psychological field included 13 items,which produced three common factors,named anxiety,depression and inferiority,and the contribution rate of accumulated variance was 65.282%.Social domain consists of five items which produces only one common factor,named social support,and the cumulative variance contribution rate is 61.056%.Therapeutic area consisted of 9 items,produced 2 common factors,named compliance and satisfaction,and the cumulative variance contribution rate was 68.832%.Item-level CVI of the scale ranges from 0.76~1.00,and the Scale-level CVI Average is 0.907.The coefficient of Cronbach's ? range from 0.783~0.896 and the retest reliability are within 0.545~0.856 range.Conclusion:The ALPRO scale is a reliable and valid instrument that can be used to reporting clinical outcomes in patients with acute leukemia.As a research tool,It may help to assess the healthy condition of the patient and provide a reference basis when discussing an individualized optimal care mode to improve patients' clinical outcomes.