| objectiveUnder the guidance of traditional Chinese medicine and Western medicine theory, we designed to develop a patient-reported outcome instrument of primary osteoporosis by some useful statistical analysis methods which based on the computer adaptive test theory and the item response theory.Method1. Establishing the research group working groupWe first established the working group of primary osteoporosis disease, Which contained a total of conceptual framework group, data management group, management group, academic committee group, experts group, academic advisory panel group and data collaboration group, and each group was composed of 3-5 people.2. Establishing the instrument featureWe designed the targeting population, the testing objective, the instrument types, the number of items, the item response grade, the scoring rules, the item management mode and the other basic features for the instrument of the primary osteoporosis.3. Specifying the basic concepts and terminology.4. Building the primarily theoretical framework of the instrumentAccording to requirements of the theoretical framework model of Central Plains project, we reviewed the foreign and Chinese instruments of quality of life in osteoporosis in order to build the instrument. After the patients and experts were questionnaired and qualitative interviewed, we then got to establish the preliminary model of the instrument.5. Constructing and screening items5.1Collecting itemsAccording to a comprehensive search of the items of primary osteoporosis in the internet, as well as reviewing the literature, national standards, treatment standards, osteoporosis instrument and some osteoporosis related descriptions. We searched all of the relevant items and formed the osteoporosis items list.5.2 Establishing an item poolThe data management group and item management group made all the primary osteoporosis list of items into a database for using.5.3Item screeningWe used the storaging and selecting methods to screen the items.5.4Revising preliminary conceptual frameworkThe conceptual framework group revised the preliminary conceptual framework model by referring to the conceptual framework which was builded before.6. Qualitative evaluation of the items6.1Experts evaluatingFirst, the data management group developed options of the item answers, and then setted the standards of the modifying, deleting, adding and stopping standards of the criterions. The experts group checked and modified on the basis of the items, and evaluated the rationality of the conceptual framework, then m odifed the results of group discussion, thus, making a consensus opinion. 6.2Core group discussingWe setted up a core group of a 6-8 people for each round, then took some meetings in discussing the inclusion and exclusion criteria for screening the items of patients with primary osteoporosis. By focusing on a group discussion, the groups are able to evaluate the rationality of the concept of system framework and then let it to the item management group for assessmenting the information.6.3The cognitive interviewEach cognitive interview participants should be at least 5 person. The group hold meetings in discussing the inclusion and exclusion criteria for screening the items of patients with primary osteoporosis. After a focus group discussions in evaluating the rationality of the concept of system framework, the item management group then assessmenting the information.7. Investigating in the hospitalsThe initial formation of patient-reported outcomes of primary osteoporosis were collected during 2013.11 to 2014.3. The investigation was carried out in patients with primary osteoporosis and the survey was held at the inpatient and outpatient departments of the third Affiliated Hospital of Guangzhou University of Chinese Medicine. 8.Satistical analysising8.1Qualitative researchFirst, we setted up the working groups, then presented the basic characteristics, the basic concepts of the instrument, the terminology, the construction tool, the preliminary theoretical framework, the construction of item database and the qualitative reviewing. All of that consist of 6 steps. The group should first analysis a qualitative on the information of the object of the study, and then make the descriptive analysis. 8.2Data analysisingWe used various kinds of Statistical methods such as discrete trends in hair Act, discrimination law, factor analysis, correlation coefficient and Cronbach’s coefficient methods in SPSS20.0 software for evaluating the items of the instrument, and used the multilog7.03 software of IRT for analysising the characteristic curves and information curves of each item in order to obtain the final instrument items. 9The scientific evoluation of the instrumentWe used the software of the CTT and IRT to evoluating the difficulty, discrimination, reliability, validity and feasibility of the instrument items.Result1.The concept of primary osteoporosisWe reviewed the relevant classical essays, the standard treatment, tne guidelines, the consensus. We then determined the primary osteoporosis’ defining as:A systemic bone disease with the absolute reduction in bone mass per unit volume, and the micro-structure was characterized by degeneration of bone tissue, resulting in increased bone fragility and an increased risk of fracture2. Initially conceptual framework of OPPROAfter reviewed and analysised the formation of the conceptual framework of the some instruments as well as some draft in foreign and Chinese of primary osteoporosis, we finally finished the researching questionnaire of the conceptual framework. We selected 10 primary osteoporosis patients and 5 experts to conduct qualitative interviews, and lastly the outcome of the frame structure was confirmed by the Academic Committee which were consisted of a conceptual framework of four areas, Including physical, psychological, social, therapeutic disease areas and six levels, which are disease manifestations, systemic manifestations, mental performance, social relations, activities of daily living, satisfaction.3. Searching the items3.1Retrievalling itemsThe Management Group recalled two domestic and two foreign relative instruments, then they got 89 and 93 items respectively. They also reviewed two standard clinical studies, and then got 52 items. At last, a total of 183 related items had been collected into the item list of the OPPRO instrument (Appendix 1).3.2Establishing the item poolThe data management group provided the structured variable items list for the patient-reported outcomes of primary osteoporosis. Making up with the element number, the serial number, the content of the item, the field of the items. Finally, the database was built by excel software. Then, the item management group structured the list of items, and thus to construct the patient-reported outcomes of primary osteoporosis item pool.3.3Item screeningWe used the storaging and selecting methods in the items’ screening, and finally, we got a instrument of 71 items ultimately, which included 24 items in systemic symptom,18 items in systemic clinical manifestations aspects,8 items in the mental aspects,8 items in the social relation aspects, 9 items in the daily activity aspects, and 4 items in the satisfaction aspects.4. Qualitative evaluation4.1Experts reviewingThe item management group were developed to coil a language needs questionnaire and the experts group then need to evaluate the rationality of conceptual framework. They finally agree with the idea of a concept frame of primary osteoporosis symptoms, systemic symptoms, physiological effect and regulating behavior. The item management group preliminary reviewed the items according to the conceptual framework, and then proposed out the amendments.4.2Core group discussing15 patients were included in two core groups into discussion for the consensus of the forming items. The instrument contained 71 items which had 18 items in systemic symptoms,18 items in systemic clinical manifestations aspects,8 items in the mental aspects,8 items in the social relation aspects, 9 items in the daily activity aspects, and 4 items in the satisfaction aspects. 4.3The cognitive interviewingBased on the steps,5 patients were being interviewed. Following with the patients’ advices, there was no need to revise the items, we then made an consensus on the ultimate item pool of the patient-reported outcomes of primary osteoporosis.5. Research on calibration test5.1Features of the diseaseDuring the time 2014.03 to 2015.02,the primary osteoporosis patients were interviewed in the Department of in-patient and out-patientof the Third Affiliated Hospital of Guangzhou University of TCM, Liwan district of Guangzhou Orthopedics Hospital of TCM, Baoan district of Shenzhen Hospital of TCM, Shunde Hospital of TCM. The patients were surveryed by field data collecting. We delivered a number of 580 instruments, and retrieved 380 whole replys in the first tested patients,52 replys in the patient with a second test,92 replys in the healthy person. The rate of the Total recovery is 90.34%.5.2Conceptual frameworkReferring to the results of the study group of patients’ and experts ’advices, then they were agreed with a conceptual framework which was defined as a four structures of "concept-field-levels-item", which included 4 fields,6 dimensions and 45 items.5.3Evaluating and adjustmenting the Conceptual frameworkThe overall Cronbach coefficient of conceptual framework was 0.801 which indicated a good internal consistency of the instrument.5.4Classical test analysisingAfter the method of factor analysising,18 items were deleted,23 items were deleted by Correlation analysising,14 items were respectively deleted by distinction and Cronbach analysising, and 3 items were deleted in discrete trend analysising5.5IRT AnalysisingA total of 25 items were deleted after the methods of analysising the discrimination and difficulty of the item characteristic curves (ICCs), the item information curve (IIC) of each item as well as the shape of the curves themselves.5.6Comprehensive analysisingBy this six methods of comprehensive evaluating, we remained the items which had been selected for 5 times among in the six methods. lastly, we got a 44 items of the final instrument of patient-reported outcomes of primary osteoporosis.6. The scientific evoluation of the instrumentAfter evaluating the reliability, the validity, the discrimination and the feasibility, we got results of them. The main symptoms of the disease Cronbach coefficient was 0.907, The systemic manifestations Coefficient was 0.780, psychological level of performance was 0.849, the level of performance of social relations was 0.807, the activities of daily living aspects was 0.799 and the satisfaction aspects was 0.877, which means the instrument had a good internal consistency. The pearson correlation coefficient was 0.925 and the Kendall correlation coefficient was 0.759 in the retesting of the instrument, indicating a good test-retest reliability. The validity analysing showed the structure of the final instrument was in accordance with the former imagination. The discrimination analysising showed a good discriminaty between the two parts when using the compared T test. The feasibility analysising showed that the instrument can be retrived in a percent of 90.34% and can be finished within 20 minutes.ConclusionBy using 5 kinds of classic statistical analysising methods and 1 kind of the item response theory analysising method in screening the items, we finally developed the patient-reported outcomes of primary osteoporosis instrument, which mainly contained 4 dimensions,6 aspects and 45 items. The reaction of the instrument was of of 1-5 levels, and the date were only collected by the patients themselves. After a comprehensive evaluation of the instrument, it showed a good data in difficulty, discrimination, reliability, validity and feasibility. The research process was rigorous, fulling of characteristics of Chinese culture and concentrating on the details of TCM. The instrument came from a strength range of ways with a high quality of the methodological and a comprehensive way in the sources of information, which meaned it was a well innovation and significant instrument.It might be also a good instrument in evaluating the efficacy of the patient reported outcomes of primary osteoporosis. |
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