Development Of A Preliminary Scale Of Patient Reported Outcome For Endometrial Dysfunction Disease

Objective: Endometrial dysfunction disease consists of two phenotypesin terms of endometriosis and adenomyosis, both of which coexist commonlyin clinic. The pathological basis of this disease is explained that endometrialtissues (including glands and stroma) of the uterus grow, flourish, andinfiltrate outside the endometrium resulting to pelvic pain and infertility ascommon clinical symptoms. Endometriosis and adenomyosis are typicallyseen in woman of child-bearing age. Due to their unknown and poorlyunderstandable aetiological agent and pathogenesis, there is no cure of thisdisease with western medicine. However, traditional Chinese medicine hasexerted potential clinical effect in improving living quality of patients.Because of lack of uniform, objective and fair assessment of clinicalefficacy of Traditional Chinese Medicine（CTM） science in disease ofendometrial dysfunction, its efficiency remains to be unpersuadable andunscientific. In this study, international evaluation system and standard wasused in order to solve this problem. It mainly includes four different aspects:report data of clinical medical staff, material of physiological data, watcherand patient reported outcome (PRO). Among them, PRO consists of furtherevaluation information like patient self description of symptoms,psychological status, activity of daily living as well as overall living qualityrelated with symptom and health. This kind of patient-centered evaluationmethod corresponds well to the key theory of the Traditional ChineseMedicine science–the holistic concept and differential treatment, and alsodisplayed superior therapeutic advantage via meliorating patient’s livingquality. Owing to its inner relation to Chinese medicine science, the treatmentefficacy of Chinese medicine can be proved by this worldwide authorizedevaluation system. To sum up, in this research work, a new scale of reported outcome from patient suffering endometrial dysfunction, The PRO is formedto effectively evaluate and access the clinical treatment efficacy ofendometriosis and adenomyosis, meanwhile providing methodology referencefor other studies of CTM and also offering breakthrough construction ofmodern and internationalized CTM.Methods: According to the internationally recognized principles ofmaking scales of reported outcome and Traditional Chinese Medicinesyndromic quantitative volume, the102cases of patients suffering endometrialdysfunction disease were interviewed and observed during a clinical follow-up,PRO and charts were documented accordingly. Afterwards, SPSS19.0software was used to analyze all data entries of the scale. All parameters anddata entries were screened through different methods: first of all, subjectiveassessment to assure importance and determinacy, secondly, dispersioncoefficient method to obtain sensible data parameter, thirdly, correlationcoefficient method was used to get representative and independent data entries,fourthly, the stepwise regression method was undertaken to sift mostlycontributive data to the scale, fifthly, via factor analysis representative, dataentries was analyzed, lastly, comprehensive analysis will merge the similardata entries, finally, an official scale is constructed.Results:1Entry distribution method:(1) From the result of frequency distribution,some data entries will be revised or obliterated due to largely occurred missinganswers, for example,‘pregnancies difficulty’,‘likely miscarriage’,‘antalgica’,‘palpable abdominal mass’,‘family stability’ were tended to beexpurgated;‘application of hot compresses and relieve dysmenorrhealmassage’ is amended to be ‘can you achieve you pain relief by the usage ofprimary analgetic treatments?’(2) The severely-skewed distributed dataentries were deleted. In this step, around21data entries were deleted.2Expert grading method:25of data entries were planned to be retained,so the data with mean value smaller than3.5333was deleted.3Discrete trends method: On the basis of a series of low-high standard deviation values,1data entries were obliterated, in terms of those of whichstandard deviation values were smaller than0.7.4Correlation coefficient method:(1) in relevance analysis ofdysmenorrheal,26data entries were deleted (P＞0.05).(2) Relevance analysisof course of disease,53data entries were deleted concerning about P＞0.05.(3) And the relevance analysis of self-rated health scores excluded20dataentries because of large P values (P＞0.05).(4) In the correlation coefficientanalysis,28data entries were deleted.5Stepwise regression: The data entries were screened for which hassignificant effect on strain Y with a criteria that P=0.35. Accordingly,31dataentries were deleted.6Comprehensive evaluation method: in synthesization of all the aboveobtained result, the proposed reservation method with a magnitude smallerthan6will be deleted. So if this value is smaller than6,30data entries werepruned away. Moreover, if the value is smaller than5,19data entries weredeleted. However, some chosen indicators between5and6should bereconsidered to maintain combining the TCM characteristics and professionalneeds. In this sense, some data entries, such as ‘Can you get any support fromsocial medical insurance system?’,‘How is your sleep recently?’, and ‘How isyour appetite?’ were reserved.7Modification of data entries and answers: the data entry like’ Do youhave dysmenorrhea’ was altered to be ‘How do you rate the pain degree ofdysmenorrheal’. The question like ‘Do you have menstrual fever’ is revised tobe ‘Do you often have a cold during the period?’. Other question such as ‘Doyou have foot, hand coldness and are vulnerable to common cold?’ wasamended to be’ How often do you have foot and hand coldness, and are youafraid of coldness?’.8To sum up, the scale of patient reported outcome for endometrialdysfunction disease which was screened from previous methods, containedphysiological function, psychological status, independence, social andinterpersonal relationship, environmental condition, in general, five aspects and in total,26data entries. In regard to the reliability, efficacy and reactivity,this scale needed to be examined further.Conclusions:1During this research work, a scale is constructed fulfilling the standardof international scale. It exhibited scientific, creative, practicable values, andthe most important, with TCM characteristics.2The investigation in this study offered valuable methodology referencesfor construction of other evaluation systems for diseases which are favorableof TCM treatment.