Abstract：
OBJECTIVE: Quality of life (QoL) is a crucial and core outcome in assessing the effectiveness of treatments for cryptoglandular anal fistula. Despite its extensive impact, there is a lack of patient-centred, disease-specific QoL measurement instruments of adequate quality. The aim of this study is to develop a disease-specific measurement instrument that can accurately measure QoL for patients with cryptoglandular anal fistula.
METHODS: Semi-structured qualitative patient interviews and a systematic review of current instruments were used to generate items for the draft instrument. This underwent successive rounds of cognitive interviews to refine its wording and structure. Individual item and overall scale content validity were determined by asking experts to rate the relevance of each item and those deemed irrelevant were removed. The final instrument then underwent psychometric testing and test-retest analysis to determine its sensitivity and stability.
RESULTS: A total of 148 patients were involved in item generation, scale development and psychometric testing. A 22-item measurement instrument has been developed; it is scored on a scale of 0-100, where 0 indicates the worst QoL and 100 demonstrates perfect QoL. The scale demonstrates excellent internal consistency (Cronbach-α = 0.927), strong content and construct validity [correlation with Perianal Disease Activity Index = -0.713, Hospital Anxiety and Depression Anxiety (-0.659) and Depression (-0.673) subscales and Short Form-12 physical (0.609) and mental (0.589) component scales] and strong reliability and responsiveness.
CONCLUSIONS: We have developed a cryptoglandular Anal Fistula Quality of Life scale (AF-QoL), a comprehensive, disease-specific patient reported outcome measure assessing QoL in patients with cryptoglandular anal fistula.
METHODS: Semi-structured qualitative patient interviews and a systematic review of current instruments were used to generate items for the draft instrument. This underwent successive rounds of cognitive interviews to refine its wording and structure. Individual item and overall scale content validity were determined by asking experts to rate the relevance of each item and those deemed irrelevant were removed. The final instrument then underwent psychometric testing and test-retest analysis to determine its sensitivity and stability.
RESULTS: A total of 148 patients were involved in item generation, scale development and psychometric testing. A 22-item measurement instrument has been developed; it is scored on a scale of 0-100, where 0 indicates the worst QoL and 100 demonstrates perfect QoL. The scale demonstrates excellent internal consistency (Cronbach-α = 0.927), strong content and construct validity [correlation with Perianal Disease Activity Index = -0.713, Hospital Anxiety and Depression Anxiety (-0.659) and Depression (-0.673) subscales and Short Form-12 physical (0.609) and mental (0.589) component scales] and strong reliability and responsiveness.
CONCLUSIONS: We have developed a cryptoglandular Anal Fistula Quality of Life scale (AF-QoL), a comprehensive, disease-specific patient reported outcome measure assessing QoL in patients with cryptoglandular anal fistula.
摘要：
目的：生活质量（QoL）是评估隐腺肛瘘治疗效果的关键和核心结果。尽管影响广泛,缺乏以病人为中心，具有足够质量的疾病特异性QoL测量仪器。本研究的目的是开发一种疾病特异性测量仪器，可以准确测量隐腺肛瘘患者的QoL。
方法：使用半结构化定性患者访谈和对当前仪器的系统评价来生成草稿仪器的项目。这经历了连续几轮的认知访谈，以完善其措辞和结构。通过要求专家对每个项目的相关性进行评分来确定单个项目和总体量表内容的有效性，并删除那些被认为不相关的项目。然后对最终仪器进行心理测试和重测分析，以确定其灵敏度和稳定性。
结果：共有148例患者参与项目生成，量表开发和心理测量测试。已经开发了22个项目的测量仪器；它的评分为0-100，其中0表示最差的QoL，100表示完美的QoL。该量表显示出优异的内部一致性(Cronbach-α=0.927)，较强的内容和结构效度[与肛周疾病活动指数=-0.713，医院焦虑和抑郁焦虑（-0.659）和抑郁（-0.673）分量表以及简短形式-12体质（0.609）和心理（0.589）分量表]和强大的可靠性和响应性。
结论：我们开发了隐腺肛瘘生活质量量表（AF-QoL），一个全面的，特定疾病患者报告了评估隐腺肛瘘患者QoL的结局指标。
方法：使用半结构化定性患者访谈和对当前仪器的系统评价来生成草稿仪器的项目。这经历了连续几轮的认知访谈，以完善其措辞和结构。通过要求专家对每个项目的相关性进行评分来确定单个项目和总体量表内容的有效性，并删除那些被认为不相关的项目。然后对最终仪器进行心理测试和重测分析，以确定其灵敏度和稳定性。
结果：共有148例患者参与项目生成，量表开发和心理测量测试。已经开发了22个项目的测量仪器；它的评分为0-100，其中0表示最差的QoL，100表示完美的QoL。该量表显示出优异的内部一致性(Cronbach-α=0.927)，较强的内容和结构效度[与肛周疾病活动指数=-0.713，医院焦虑和抑郁焦虑（-0.659）和抑郁（-0.673）分量表以及简短形式-12体质（0.609）和心理（0.589）分量表]和强大的可靠性和响应性。
结论：我们开发了隐腺肛瘘生活质量量表（AF-QoL），一个全面的，特定疾病患者报告了评估隐腺肛瘘患者QoL的结局指标。
