本文選題：慢性阻塞性肺病（COPD） + 患者報告的臨床結(jié)局量表（PRO）��； 參考：《山西醫(yī)科大學(xué)》2012年碩士論文

【摘要】：研究目的：根據(jù)美國食品及藥物管理局（FDA）規(guī)定的PRO量表制作原則與流程，從患者角度編制基于慢性阻塞性肺病患者報告的臨床結(jié)局評價量表（PRO量表），通過預(yù)調(diào)查以及大樣本的臨床正式調(diào)查，修訂量表，并對其計量心理學(xué)特征做出評價。 研究方法：遵循國際量表研制的流程規(guī)范，以慢性阻塞性肺病的理論知識為基礎(chǔ)，通過文獻(xiàn)查閱以及患者訪談、借鑒國內(nèi)外相關(guān)量表形成量表域結(jié)構(gòu)及條目池，之后由多位各領(lǐng)域?qū)＜覍l目池進(jìn)行修改，做小范圍調(diào)查進(jìn)行語言調(diào)試，形成初量表。通過預(yù)調(diào)查對條目進(jìn)行初步篩選和調(diào)整，形成正式量表。于醫(yī)院及社區(qū)展開現(xiàn)場調(diào)查獲得樣本，評價終量表的信度、效度、反應(yīng)度等各指標(biāo)，經(jīng)過調(diào)整，形成終量表。 研究結(jié)果：1．形成基于慢性阻塞性肺病患者報告的臨床結(jié)局評價量表。量表由生理領(lǐng)域、心理領(lǐng)域、社會領(lǐng)域、治療領(lǐng)域4個一級維度組成，其中生理領(lǐng)域包括特異性癥狀、全身癥狀、獨(dú)立性3個方面；心理領(lǐng)域包括焦慮、抑郁2個方面；社會領(lǐng)域包括疾病認(rèn)知、疾病對社會活動的影響、社會支持度3個方面；治療領(lǐng)域包括依從性、藥物副作用、滿意度3個方面，共11個二級維度。量表包含52個條目。2．對395例有效數(shù)據(jù)進(jìn)行分析。結(jié)果顯示該量表評價慢性阻塞性肺病患者具有較好的信度、效度、反應(yīng)度及臨床可行性。分半信度系數(shù)：生理領(lǐng)域0.762，心理領(lǐng)域0.865，社會領(lǐng)域0.755，治療領(lǐng)域0.862，整個量表0.757�？死拾秃障禂�(shù)：生理領(lǐng)域0.888，，心理領(lǐng)域0.898，社會領(lǐng)域0.704，治療領(lǐng)域0.696，整個量表0.923。 研究結(jié)論：根據(jù)FDA的規(guī)定，我們研制出基于慢性阻塞性肺病患者報告的臨床結(jié)局評價量表。將經(jīng)典測量方法和項目反應(yīng)理論結(jié)合對量表進(jìn)行評價。結(jié)果表明：該量表具有較好的信度、效度、反應(yīng)度和臨床可行性,可以作為慢性阻塞性肺病臨床療效評價研究的工具。
[Abstract]:Objective: according to the principle and procedure of the pro scale made by the Food and Drug Administration (FDA), The clinical outcome evaluation scale (pro) based on the report of patients with chronic obstructive pulmonary disease (COPD) was compiled from the patient's point of view. The scale was revised by pre-investigation and a large sample of clinical formal investigation, and the characteristics of econometric psychology were evaluated. Methods: according to the procedure of international scale development, based on the theoretical knowledge of chronic obstructive pulmonary disease (COPD), through literature review and patient interviews, the scale domain structure and item pool were formed by referring to the relevant scales at home and abroad. After that, a number of experts in various fields modify the item pool, do a small survey to debug the language, and form a preliminary scale. Through preliminary screening and adjustment of items through pre-investigation, a formal scale was formed. Field investigation was carried out in hospitals and communities to obtain samples and evaluate the reliability, validity and response of the final scale, which were adjusted to form the final scale. Results: 1. A clinical outcome evaluation scale based on COPD patient reports was developed. The scale consists of four dimensions: physiological field, psychological field, social field and therapeutic field, in which the physiological field includes three aspects: specific symptom, systemic symptom, independence, anxiety and depression. The social domain includes disease cognition, the influence of disease on social activities, social support degree, and the treatment field includes compliance, side effects of drugs and satisfaction, which are 11 second-order dimensions. The data of 395 cases were analyzed. The results showed that the scale had good reliability, validity, response and clinical feasibility in evaluating patients with chronic obstructive pulmonary disease (COPD). Split-half reliability coefficient: physiological field 0.762, psychological field 0.865, social field 0.755, treatment field 0.862. the whole scale 0.757. Cronbach coefficient: physiological field 0.888, psychological field 0.898, social field 0.704, therapeutic field 0.696, whole scale 0.923. Conclusion: in accordance with FDA guidelines, we developed a clinical outcome evaluation scale based on chronic obstructive pulmonary disease (COPD) reports. The classical measurement method and item response theory were combined to evaluate the scale. The results showed that the scale had good reliability, validity, response and clinical feasibility, and could be used as a tool to evaluate the clinical efficacy of chronic obstructive pulmonary disease (COPD).
【學(xué)位授予單位】：山西醫(yī)科大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2012
【分類號】：R563.9

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