偏头痛基于患者报告的结局评价量表研制及性能初步考评
摘要
研究目的
偏头痛是严重影响人类健康和生活质量的复发缓解类疾病,其防治和疗效评价是医学界研究的热点。中医药治疗偏头痛缓解期疗效明确,但目前的疗效评价局限于对头痛发作情况本身的评价,或虽然加入中医证候评分,仍忽略了对患者心理情感和功能状态的评价。随着社会的进步,疗效评价逐步开始关注患者报告的结局(PRO)资料,而中医问诊收集的资料与PRO资料均来自于患者,二者具有内在相似性。偏头痛是以患者主观感受为主的复发缓解类疾病,疗效评价既要注重对头痛发作情况的评价,又要重视对能力状态、精神心理状态和生存质量等患者报告资料的评价。本研究借鉴国际PRO量表研制方法,从偏头痛疾病特点出发,探索研制偏头痛基于患者报告的结局评价量表,进一步丰富和完善偏头痛疗效评价方法。
研究方法
1构建理论框架,形成条目池参照美国FDA发布的PRO量表研制具体说明,遵照量表学的原理及要求,成立研究小组,在查阅文献的基础上,采用小组讨论的方式,构建了科学的量表理论框架,对量表的维度作了明确的界定。从现代102例中医头痛医案中筛选出现频率三5%的症状,同时从218例临床病例中筛选出现频率≥5%且经治疗显著变化的症状,结合患者访谈,研究小组讨论和提炼,确定PRO量表的条目池。
2量表条目筛选根据构建的理论框架和初步确定的条目池编制第1轮专家调查问卷,运用德尔菲法咨询全国中医脑病专家,依据专家支持率和专家建议,结合研究小组讨论,对条目进行合并、增减和完善。将修改完善后的条目编制第2轮专家问卷进行调查,通过条目得分均值、等级和、满分比、变异系数、权重系数等指标分析专家问卷,最终确定量表条目。
3形成量表初稿经过条目筛选,最终确定了属于4个维度的12个条目(头痛发作情况4条、躯体不适4条、心理情感2条、社会功能2条)。经研究小组讨论,采用Likert 5级评分法,编制卷首语,制定详细的填表说明,完成量表条目和格式设计,形成量表初稿。
4量表初稿的性能考评2011.1～2011.3,在北京中医药大学东直门医院脑病科和头痛专科门诊进行偏头痛PRO量表初稿的临床测评,收集病例并建立数据库,采用SPSS13.0统计软件进行数据分析,考评量表的可行性、信度、效度和反应度等。
研究结果
1条目池筛选头痛医案、临床研究病例、患者访谈共筛选指标55条,包括描述头痛程度、部位、性质以及诱因的19条,描述头痛以外的躯体症状、心理情感的32条,关于功能状态的4条。经研究小组讨论,初步确定包含33个条目的偏头痛PRO量表条目池。
2条目筛选与优化第1轮专家问卷调查后,删除支持率<70%的7个条目,研究小组整理专家建议并多次讨论,将条目整合为12条。第2轮专家调查中,专家对条目的重要性和可操作性评价一致性较高,除“疲乏无力”的重要性变异系数为26.57%>25%外,其他条目重要性和可操作性评价的变异系数均<25%,说明专家意见协调性好,量表所设条目的重要性高且临床可操作性良好,故未对条目进行删减和修改,确定了偏头痛PRO量表初稿的12个条目。通过专家对条目重要性的评分,采用百分权重法确定各条目权重系数,结果显示各条目权重系数相当,故将量表各条目权重视作相等。
3量表性能考评
(1)量表可行性发放问卷30份,回收30份,完成问卷30份,接收率、完成率均为100%。前后2次量表测评平均完成时间分别为3.55分钟和3.48分钟,量表条目简单明了,测评时间较为理想,保证了量表测评中患者的依从性,可行性良好。
(2)项目区分度运用相关系数衡量量表项目区分度,结果12个条目中除“睡眠障碍”的区分度指数为0.247<0.3外,其他条目的区分度指数均>0.3,量表项目区分度良好。
(3)量表信度前后2次量表测评结果的分半信度分别为0.827和0.932,该量表具有较高的跨条目一致性。前后2次量表测评结果的Cronbach's a系数分别为0.784和0.905,说明量表具有很高的内部一致性,整体信度良好。
(4)量表效度从量表的编制过程、量表各条目得分与其所属维度得分的相关性及与其他维度得分的相关性来看,该量表具有较好的内容效度。以SF-36和VAS作为标准量表考核量表的标准效度,结果前后2次测评PRO总分与SF-36总分呈负相关,相关系数分别为-0.594和-0.629；前后2次测评PRO总分与VAS评分呈正相关,相关系数分别为0.321和0.757,表明量表标准效度良好。运用验证性因子分析考评量表的结构效度,结构方程模型的拟合优度指数(CFI)值为0.88,因此认为量表内部结构与理论假设是可以拟合的,该量表具有较好的结构效度。
(5)量表反应度本PRO量表的效应尺度为1.37,前后2次得分配对t检验,t=7.93,P<0.01；前后两次各条目、各维度经配对t检验或非参数秩和检验,除“近4周,您有情绪低落或精神不振吗”(P=0.07)条目反应度相对较差外,4个维度和其他11个条目均是P<0.05,说明该量表具有较好的反应度,能反应出患者健康状况随时间改变而发生的细微变化。
(6)将PRO量表评分好转率与患者总体自评好转程度做相关分析,发现二者呈正相关,相关系数0.702,量表具有真实反映患者自觉症状变化的能力。结论
将PRO研究方法引入到偏头痛的临床疗效评价研究中,基于中医特色,结合偏头痛的临床特点,严格参照美国FDA发布的PRO量表研制具体说明和步骤,制定了偏头痛PRO量表。该量表具有较好的信度、效度和反应度,可行性良好,具有真实反映偏头痛患者自觉症状变化的能力,本量表的研制将丰富和完善偏头痛的临床疗效评价方法,并为复发缓解类疾病的中医药临床疗效评价研究提供参考。
Objective
Migraine is characterized by remission and relapse, it affects human health and quality of life seriously, prevention and effect assessment of migraine is a hotspot in the field of medical. The curative effect of TCM for migraine interictal is clear, but the current effect assessment confined to headache, or even though join syndromes grading, it's still ignore patients' psychological emotion and social function evaluation. With the develpoment of society, efficacy evaluation begin to pay close attention to the patients-reported outcomes (PRO) gradually, while data collected by TCM inquiry and PRO internally consistent with each other. Migraine is a recurrent alleviate disease, subjective feeling of patients is the main character of it. Efficacy evaluation should not only emphasize the headache, but also pay close attention to the state of mental state, ability and quality of life from patient-reported outcomes. In order to enrich and perfect the migraine curative effect evaluation, this research refers to the method of PRO development in international, base on the characteristics of migraine, explore to develop the PRO scale of migraine.
Methods
1 Construct theoretical framework and Form Item-Bank Refer to the Specific instructions of PRO research issued by the U.S.FDA, comply with the principle and requirement of Scale. Form a research team, on the basis of literature, through group discussion, build a scientific rigorous theoretical framework of scale, and make clear definition of the dimensionality of scale. From 102 medical records about headache in modern times to chose symptoms which frequency appears≥5% in all, and 218 clinical cases collected in previous trails, chose symptoms which frequency appears=≥5% and significantly changed(P≤0.05) after treatment, in conjunction with the patient interview, through group discussion and refining, confirmed the item-banks of PRO scale.
2 Items selection According to the built theoretical framework and measurable symptoms indexes to design experts questionnaire, consulting experts who have long-term clinical study in brian department by Delphi method. After the first round of questionnaire, according to experts approval ratings and advices, in conjunction with discussion of research team, combining, increasing or decreasing items. Then, design experts questionnaire for the second round, analyse questionnaire through the mean, sum of grade score, rate of full marks, and coefficient of variation, weight coefficient.
3 Form the draft scale After items selection, the scale item-banks which are consisted of 4 dimensionality included 12 items (5 items of headache dimensionality,4 items of physical dimensionality,2 items of psychological dimensionality,2 items of social dimensionality) was formed. After the discussion of research group, adopt Likert-5 to design score by five, identified foreword, developed detailed instruction, completed the format of scale, the draft scale formed.
4 Clinical validation of the draft scale From January 2011 to March 2011, we collected clinical datas from the Headache specialist out-patient of Dongzhimen hospital which affiliated to Beijing University of TCM for clinical validation of the draft scale, developed the database, analysised the datas by SPSS13.0 software, studied the application of the crowd of the scale and evaluated the scale reliability, validity and responsiveness.
Results
1 Item-Bank selection 55 items were selected from medical records and clinical cases and patient interview, included 19 items of headache degree, parts, nature and the incentive; 32 items of Somatic symptoms, psychological emotion; 4 items of function damage. After group discussion, preliminarily determine 33 symptoms can be used for clinical efficacy evaluation about migraine.
2 Items selection and optimization Deleted 7 items which support rate< 70% after the first round of experts questionnaire, shaped up experts'suggestion and repeatedly discussed,12 items were integration. In the second round experts investigation, experts' opinions about the importance and operability of items was more consistency, excepts'CV about the importance of "exhaustion" was 26.57%> 25%, CV about other items were< 25%, experts'advice were coordinately, so the scale draft which consisted of 4 dimensionality include 12 items was formed. Based on the score of importance of items, using percentage weight method to determine the weight of every item, the result showed that there were little difference among the weight of all items, so we regard every item as equal weight.
3 Clinical validation cf the draft scale
(1)Operability of PRO scale 30 copies of questionnaires were delivered and took back, all 30 copied were completed, both acceptance rate and completion rate were 100%, completion time before and after treatment was 3.48 minutes and 3.55 minutes respectively, so items of this scale is terse and perspicuous, test time is ideal, ensure patient compliance during scale assessment.
(2)Item discrimination Using correlation coefficient to measure Item discrimination of the scale, item discrimination of all items were>0.3, except "Sleep disorders" (0.247<0.3). The item discrimination of PRO scale is good.
(3)Reliability of the scale The results showed that the split-half reliability of the scale one after another were 0.827 and 0.932, which indicated that the scale had high across entries consistency, overall reliability of 12 items showed Cronbach's Alpha coefficients were 0.784 and 0.905, indicated that the reliability of the scale is acceptable in general.
(4)Validity of the scale Judging from the develop process, the correlation between entries score and its subordinate dimensionality score or other dimensionalities score, the scale has good content validity. Selected the SF-36 scale and VAS scale as school marked to study the standard validity. The results showed:total score of PRO and SF-36 one after anther were negatively correlated, the correlation coefficients were -0.594 and -0.629, total score of PRO and VAS one after anther were positively correlated, the correlation coefficients were 0.321 and -0.757, the standard validity of the scale was good. Studied construct validity of the scale by confirmatory factor analysis, results showed the comparative fit index (CFI) was 0.88, showed that internal structure of the scale can be fit in theoretical assumptions, so the scale has good construct validity.
(5)Effect magnitude of the scale Effect magnitude of the scale is 1.37, paired T test of the total scores, t=7.93,P<0.01; Each items and each dimensionality of the PRO scale before and after analysised by paired T test or non-parametric rank sum test, all P values were<0.05, statistically significant results, except "depression in recent 4 weeks" (P=0.07), indicated that the scales had good responsiveness, it can reflect changes over time changes of the patients' quality of life.
(6)Correlation analysis was performed according to improvement rate of PRO and patients self-assessment, results showed that they were positively correlated, correlation coefficient was 0.702, in other words the scale has ability to show the changes of patient self-conscious symptoms.
Conclusions
In this study, we introduced the method of PRO which were internationally recognized into clinical study of migraine, and based on the theory of TCM, combined with the clinical characteristics of migraine, formulated migraine PRO Scale.The scale has good reliability and validity and reactivity and feasibility, has ability to show changes of self-conscious symptoms of migraineur truly.This will enrich and perfect the methods of clinical efficacy evaluation of migraine appraisal, and provide reference for evaluation of therapeutic efficiency of TCM research about the recurrence alleviate diseases.
偏头痛是严重影响人类健康和生活质量的复发缓解类疾病,其防治和疗效评价是医学界研究的热点。中医药治疗偏头痛缓解期疗效明确,但目前的疗效评价局限于对头痛发作情况本身的评价,或虽然加入中医证候评分,仍忽略了对患者心理情感和功能状态的评价。随着社会的进步,疗效评价逐步开始关注患者报告的结局(PRO)资料,而中医问诊收集的资料与PRO资料均来自于患者,二者具有内在相似性。偏头痛是以患者主观感受为主的复发缓解类疾病,疗效评价既要注重对头痛发作情况的评价,又要重视对能力状态、精神心理状态和生存质量等患者报告资料的评价。本研究借鉴国际PRO量表研制方法,从偏头痛疾病特点出发,探索研制偏头痛基于患者报告的结局评价量表,进一步丰富和完善偏头痛疗效评价方法。
研究方法
1构建理论框架,形成条目池参照美国FDA发布的PRO量表研制具体说明,遵照量表学的原理及要求,成立研究小组,在查阅文献的基础上,采用小组讨论的方式,构建了科学的量表理论框架,对量表的维度作了明确的界定。从现代102例中医头痛医案中筛选出现频率三5%的症状,同时从218例临床病例中筛选出现频率≥5%且经治疗显著变化的症状,结合患者访谈,研究小组讨论和提炼,确定PRO量表的条目池。
2量表条目筛选根据构建的理论框架和初步确定的条目池编制第1轮专家调查问卷,运用德尔菲法咨询全国中医脑病专家,依据专家支持率和专家建议,结合研究小组讨论,对条目进行合并、增减和完善。将修改完善后的条目编制第2轮专家问卷进行调查,通过条目得分均值、等级和、满分比、变异系数、权重系数等指标分析专家问卷,最终确定量表条目。
3形成量表初稿经过条目筛选,最终确定了属于4个维度的12个条目(头痛发作情况4条、躯体不适4条、心理情感2条、社会功能2条)。经研究小组讨论,采用Likert 5级评分法,编制卷首语,制定详细的填表说明,完成量表条目和格式设计,形成量表初稿。
4量表初稿的性能考评2011.1～2011.3,在北京中医药大学东直门医院脑病科和头痛专科门诊进行偏头痛PRO量表初稿的临床测评,收集病例并建立数据库,采用SPSS13.0统计软件进行数据分析,考评量表的可行性、信度、效度和反应度等。
研究结果
1条目池筛选头痛医案、临床研究病例、患者访谈共筛选指标55条,包括描述头痛程度、部位、性质以及诱因的19条,描述头痛以外的躯体症状、心理情感的32条,关于功能状态的4条。经研究小组讨论,初步确定包含33个条目的偏头痛PRO量表条目池。
2条目筛选与优化第1轮专家问卷调查后,删除支持率<70%的7个条目,研究小组整理专家建议并多次讨论,将条目整合为12条。第2轮专家调查中,专家对条目的重要性和可操作性评价一致性较高,除“疲乏无力”的重要性变异系数为26.57%>25%外,其他条目重要性和可操作性评价的变异系数均<25%,说明专家意见协调性好,量表所设条目的重要性高且临床可操作性良好,故未对条目进行删减和修改,确定了偏头痛PRO量表初稿的12个条目。通过专家对条目重要性的评分,采用百分权重法确定各条目权重系数,结果显示各条目权重系数相当,故将量表各条目权重视作相等。
3量表性能考评
(1)量表可行性发放问卷30份,回收30份,完成问卷30份,接收率、完成率均为100%。前后2次量表测评平均完成时间分别为3.55分钟和3.48分钟,量表条目简单明了,测评时间较为理想,保证了量表测评中患者的依从性,可行性良好。
(2)项目区分度运用相关系数衡量量表项目区分度,结果12个条目中除“睡眠障碍”的区分度指数为0.247<0.3外,其他条目的区分度指数均>0.3,量表项目区分度良好。
(3)量表信度前后2次量表测评结果的分半信度分别为0.827和0.932,该量表具有较高的跨条目一致性。前后2次量表测评结果的Cronbach's a系数分别为0.784和0.905,说明量表具有很高的内部一致性,整体信度良好。
(4)量表效度从量表的编制过程、量表各条目得分与其所属维度得分的相关性及与其他维度得分的相关性来看,该量表具有较好的内容效度。以SF-36和VAS作为标准量表考核量表的标准效度,结果前后2次测评PRO总分与SF-36总分呈负相关,相关系数分别为-0.594和-0.629；前后2次测评PRO总分与VAS评分呈正相关,相关系数分别为0.321和0.757,表明量表标准效度良好。运用验证性因子分析考评量表的结构效度,结构方程模型的拟合优度指数(CFI)值为0.88,因此认为量表内部结构与理论假设是可以拟合的,该量表具有较好的结构效度。
(5)量表反应度本PRO量表的效应尺度为1.37,前后2次得分配对t检验,t=7.93,P<0.01；前后两次各条目、各维度经配对t检验或非参数秩和检验,除“近4周,您有情绪低落或精神不振吗”(P=0.07)条目反应度相对较差外,4个维度和其他11个条目均是P<0.05,说明该量表具有较好的反应度,能反应出患者健康状况随时间改变而发生的细微变化。
(6)将PRO量表评分好转率与患者总体自评好转程度做相关分析,发现二者呈正相关,相关系数0.702,量表具有真实反映患者自觉症状变化的能力。结论
将PRO研究方法引入到偏头痛的临床疗效评价研究中,基于中医特色,结合偏头痛的临床特点,严格参照美国FDA发布的PRO量表研制具体说明和步骤,制定了偏头痛PRO量表。该量表具有较好的信度、效度和反应度,可行性良好,具有真实反映偏头痛患者自觉症状变化的能力,本量表的研制将丰富和完善偏头痛的临床疗效评价方法,并为复发缓解类疾病的中医药临床疗效评价研究提供参考。
Objective
Migraine is characterized by remission and relapse, it affects human health and quality of life seriously, prevention and effect assessment of migraine is a hotspot in the field of medical. The curative effect of TCM for migraine interictal is clear, but the current effect assessment confined to headache, or even though join syndromes grading, it's still ignore patients' psychological emotion and social function evaluation. With the develpoment of society, efficacy evaluation begin to pay close attention to the patients-reported outcomes (PRO) gradually, while data collected by TCM inquiry and PRO internally consistent with each other. Migraine is a recurrent alleviate disease, subjective feeling of patients is the main character of it. Efficacy evaluation should not only emphasize the headache, but also pay close attention to the state of mental state, ability and quality of life from patient-reported outcomes. In order to enrich and perfect the migraine curative effect evaluation, this research refers to the method of PRO development in international, base on the characteristics of migraine, explore to develop the PRO scale of migraine.
Methods
1 Construct theoretical framework and Form Item-Bank Refer to the Specific instructions of PRO research issued by the U.S.FDA, comply with the principle and requirement of Scale. Form a research team, on the basis of literature, through group discussion, build a scientific rigorous theoretical framework of scale, and make clear definition of the dimensionality of scale. From 102 medical records about headache in modern times to chose symptoms which frequency appears≥5% in all, and 218 clinical cases collected in previous trails, chose symptoms which frequency appears=≥5% and significantly changed(P≤0.05) after treatment, in conjunction with the patient interview, through group discussion and refining, confirmed the item-banks of PRO scale.
2 Items selection According to the built theoretical framework and measurable symptoms indexes to design experts questionnaire, consulting experts who have long-term clinical study in brian department by Delphi method. After the first round of questionnaire, according to experts approval ratings and advices, in conjunction with discussion of research team, combining, increasing or decreasing items. Then, design experts questionnaire for the second round, analyse questionnaire through the mean, sum of grade score, rate of full marks, and coefficient of variation, weight coefficient.
3 Form the draft scale After items selection, the scale item-banks which are consisted of 4 dimensionality included 12 items (5 items of headache dimensionality,4 items of physical dimensionality,2 items of psychological dimensionality,2 items of social dimensionality) was formed. After the discussion of research group, adopt Likert-5 to design score by five, identified foreword, developed detailed instruction, completed the format of scale, the draft scale formed.
4 Clinical validation of the draft scale From January 2011 to March 2011, we collected clinical datas from the Headache specialist out-patient of Dongzhimen hospital which affiliated to Beijing University of TCM for clinical validation of the draft scale, developed the database, analysised the datas by SPSS13.0 software, studied the application of the crowd of the scale and evaluated the scale reliability, validity and responsiveness.
Results
1 Item-Bank selection 55 items were selected from medical records and clinical cases and patient interview, included 19 items of headache degree, parts, nature and the incentive; 32 items of Somatic symptoms, psychological emotion; 4 items of function damage. After group discussion, preliminarily determine 33 symptoms can be used for clinical efficacy evaluation about migraine.
2 Items selection and optimization Deleted 7 items which support rate< 70% after the first round of experts questionnaire, shaped up experts'suggestion and repeatedly discussed,12 items were integration. In the second round experts investigation, experts' opinions about the importance and operability of items was more consistency, excepts'CV about the importance of "exhaustion" was 26.57%> 25%, CV about other items were< 25%, experts'advice were coordinately, so the scale draft which consisted of 4 dimensionality include 12 items was formed. Based on the score of importance of items, using percentage weight method to determine the weight of every item, the result showed that there were little difference among the weight of all items, so we regard every item as equal weight.
3 Clinical validation cf the draft scale
(1)Operability of PRO scale 30 copies of questionnaires were delivered and took back, all 30 copied were completed, both acceptance rate and completion rate were 100%, completion time before and after treatment was 3.48 minutes and 3.55 minutes respectively, so items of this scale is terse and perspicuous, test time is ideal, ensure patient compliance during scale assessment.
(2)Item discrimination Using correlation coefficient to measure Item discrimination of the scale, item discrimination of all items were>0.3, except "Sleep disorders" (0.247<0.3). The item discrimination of PRO scale is good.
(3)Reliability of the scale The results showed that the split-half reliability of the scale one after another were 0.827 and 0.932, which indicated that the scale had high across entries consistency, overall reliability of 12 items showed Cronbach's Alpha coefficients were 0.784 and 0.905, indicated that the reliability of the scale is acceptable in general.
(4)Validity of the scale Judging from the develop process, the correlation between entries score and its subordinate dimensionality score or other dimensionalities score, the scale has good content validity. Selected the SF-36 scale and VAS scale as school marked to study the standard validity. The results showed:total score of PRO and SF-36 one after anther were negatively correlated, the correlation coefficients were -0.594 and -0.629, total score of PRO and VAS one after anther were positively correlated, the correlation coefficients were 0.321 and -0.757, the standard validity of the scale was good. Studied construct validity of the scale by confirmatory factor analysis, results showed the comparative fit index (CFI) was 0.88, showed that internal structure of the scale can be fit in theoretical assumptions, so the scale has good construct validity.
(5)Effect magnitude of the scale Effect magnitude of the scale is 1.37, paired T test of the total scores, t=7.93,P<0.01; Each items and each dimensionality of the PRO scale before and after analysised by paired T test or non-parametric rank sum test, all P values were<0.05, statistically significant results, except "depression in recent 4 weeks" (P=0.07), indicated that the scales had good responsiveness, it can reflect changes over time changes of the patients' quality of life.
(6)Correlation analysis was performed according to improvement rate of PRO and patients self-assessment, results showed that they were positively correlated, correlation coefficient was 0.702, in other words the scale has ability to show the changes of patient self-conscious symptoms.
Conclusions
In this study, we introduced the method of PRO which were internationally recognized into clinical study of migraine, and based on the theory of TCM, combined with the clinical characteristics of migraine, formulated migraine PRO Scale.The scale has good reliability and validity and reactivity and feasibility, has ability to show changes of self-conscious symptoms of migraineur truly.This will enrich and perfect the methods of clinical efficacy evaluation of migraine appraisal, and provide reference for evaluation of therapeutic efficiency of TCM research about the recurrence alleviate diseases.
引文
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