| Objective To develop and evaluate the Quality of Life (QOL)Instrument for Patients with Chronic Renal Failure(QLICD-CRF) fitting for Chinese by procedural methods; Combining with SF-36to formulate Clinical minimum significantly different(MID) through anchor-based and distribution-based methods; To analyze the influence factors of quality of life in patients with chronic renal failure.Methods The specific modules'theoretical framework and item pool were proposed, after discussion of experts, the screened items were used to form a specific module for pilot test. Based on the pilot test data and methods of coefficient of variation, correlation analysis, importance rating procedure, and focus group discussion again to form specific module for the Quality of Life Instrument for Patients with Chronic Renal Failure beta version (QLICD-CRF beta version)(a general modules plus specific modules). The QLICD-CRF beta version was used to collect data and re-screen items by methods of coefficient of variation, factor analysis correlation analysis, and then, the Quality of Life Instrument for Patients with Chronic Renal Failure(QLICD-CRF) was developed. After development, psychological characteristics were evaluated based on Classical Test Theory (CTT) and Generalizability Theory(GT). Besides, the clinical minimum significantly difference (MID) through anchor-based and distribution-based methods for different domains of QLICD-CRF were computed. In addition, the influence factors of quality of life in patients with chronic renal failure factors were analyzed.Results(1) After pilot study, combining statistic analysis with expert s'discussion, there were13items of specific modules;(2) The result of re-screening item was that the specific modules constituted by3aspects (10items);(3) Based on the generalized theoretical results, generalized coefficient and reliability coefficient in Physical, psychological, social and the specific module domains were good;(4) Assessment of QLICD-CRF①reliability:test-retest reliability of every domain and facet was above0.8, almost all of the internal consistency reliability was larger than0.6except ASU, COG, SSS and SOR, the total internal consistency reliability was0.90, total split-half reliability was0.76;②validity:QLICD-CRF had a good content validity; regarding construct validity, most of coefficients of correlation between item and its domain were larger, factor analysis extracted three principal components, the cumulated variance accounted for57.36%; Using SF-36as criterion, the correlation coefficient of corresponding domains were higher than others;③responsiveness:except the psychological, social function domains, all others had statistical significance by paired t test, and standardized reaction mean (SRM) were PDH0.64,SPD0.65,CGD0.23,TOT0.51respectively. At facets level, there was no statistical significance in COG,EMO,WIL of PSD and all of the facets of SOD, but all others were statistical significant;(5) Explanation of scale score and Clinical minimum significantly difference (MID):in this study, MID based on anchor-based method was just reference, it couldn't be see as criterion because of the sample size, and the MID assessed through distribution-based method was meaningful, so MID of PHD wa8.69,PSD was10.16, SOD was8.28CGD was7.94,SPDw as9.66,TOT was8.10(standardized scores)(6) The influence factors of quality of life in patients with chronic renal failure:the influence factors of QOL measured by two scales of SF-36and QLICD-CRF were analyzed, with the overall results showing that factors were age, nationality, occupation, family economic status, and the course, the amount of hemoglobin and clinical stage. Conclusion The development of QLICD-CRF was scientific, orderly, reasonable, and it has good validity, reliability and responsiveness. QLICD-CRF can be used to measure QOL for Chinese patients with chronic renal failure. At the same time, clinicians can use it to evaluate treatments. Because QLICD-CRF was developed by regarding Chinese culture as background, so it provides a good foundation and platform for evaluation of QOL of Chinese patients with chronic renal failure. Investigators can get the authentic, specific and effective data and information of Chinese people by using QLICD-CRF, which can improve the quality of the research and evaluation. |
PDF Full Text Request