目的系统评价中文版炎症性肠病残疾测量工具的测量学特性及方法学质量。方法本研究系统检索PubMed、Web of Science数据库及中国知网、万方数据库、维普数据库中与炎症性肠病患者残疾测量工具测量学特性评价相关的研究,检索时限为建库至...目的系统评价中文版炎症性肠病残疾测量工具的测量学特性及方法学质量。方法本研究系统检索PubMed、Web of Science数据库及中国知网、万方数据库、维普数据库中与炎症性肠病患者残疾测量工具测量学特性评价相关的研究,检索时限为建库至2023年9月12日。依据健康测量工具遴选标准(COSMIN)要求,由2名研究者独立进行文献筛选和资料提取。采用COSMIN偏倚风险清单及质量标准评定工具的测量学特性并形成最终推荐意见。结果本研究共纳入5篇文献,涉及4种中文版炎症性肠病残疾测量工具。纳入研究均未完整报告COSMIN方法学质量推荐的共10项测量特性,最终纳入的研究工具均为B级或C级推荐。结论推荐临床可暂时使用中文版炎症性肠病残疾指数、汉化版炎症性肠病患者疾病负担程度量表评估炎症性肠病患者的残疾情况,但其测量学特性尚需进一步验证。展开更多
Background and aims: Ulcerative colitis disease activity indices offer good statistical power but small changes in these indices may not be clinically important. There are no validated definitions of remission or of s...Background and aims: Ulcerative colitis disease activity indices offer good statistical power but small changes in these indices may not be clinically important. There are no validated definitions of remission or of significant improvement for these indices. The use of clinically important end points would strengthen the validity of study outcomes. Our aims were to identify objective end points in standard disease activity indices for remission and for improvement in ulcerative colitis. Methods: Sixty six consecutive patients with ulcerative colitis provided information about remission status and their disease activity. At a return visit 1-14 months later, these patients provided information about the change in their disease activity, and non-invasive indices were measured. Results: Specific objective end points for determining remission with four standard indices and a quality of life instrument were deter mined (St Mark’s < 3.5, ulcerative colitis disease activity index < 2.5, simple clinical colitis activity index (SCCAI) < 2.5, Seo < 120, and inflammatory bowel disease quality of life index (IBDQ) >205). These cut offs also identified patients who met a regulatory definition of remission. Specific objective end points for clinical improvement in two non-invasive indices and a quality of life instrument were determined with good sensitivity and specificity (SCCAI decrease >1.5, Seo decrease >30, IBDQ increase >20). Conclusions: We found specific cut off values for disease activity indices that identify patients who have significantly improved or achieved remission in an objective, sensitive, and specific manner. These cut offs should help in the interpretation of the outcomes of clinical trials in ulcerative colitis.展开更多
文摘目的系统评价中文版炎症性肠病残疾测量工具的测量学特性及方法学质量。方法本研究系统检索PubMed、Web of Science数据库及中国知网、万方数据库、维普数据库中与炎症性肠病患者残疾测量工具测量学特性评价相关的研究,检索时限为建库至2023年9月12日。依据健康测量工具遴选标准(COSMIN)要求,由2名研究者独立进行文献筛选和资料提取。采用COSMIN偏倚风险清单及质量标准评定工具的测量学特性并形成最终推荐意见。结果本研究共纳入5篇文献,涉及4种中文版炎症性肠病残疾测量工具。纳入研究均未完整报告COSMIN方法学质量推荐的共10项测量特性,最终纳入的研究工具均为B级或C级推荐。结论推荐临床可暂时使用中文版炎症性肠病残疾指数、汉化版炎症性肠病患者疾病负担程度量表评估炎症性肠病患者的残疾情况,但其测量学特性尚需进一步验证。
文摘Background and aims: Ulcerative colitis disease activity indices offer good statistical power but small changes in these indices may not be clinically important. There are no validated definitions of remission or of significant improvement for these indices. The use of clinically important end points would strengthen the validity of study outcomes. Our aims were to identify objective end points in standard disease activity indices for remission and for improvement in ulcerative colitis. Methods: Sixty six consecutive patients with ulcerative colitis provided information about remission status and their disease activity. At a return visit 1-14 months later, these patients provided information about the change in their disease activity, and non-invasive indices were measured. Results: Specific objective end points for determining remission with four standard indices and a quality of life instrument were deter mined (St Mark’s < 3.5, ulcerative colitis disease activity index < 2.5, simple clinical colitis activity index (SCCAI) < 2.5, Seo < 120, and inflammatory bowel disease quality of life index (IBDQ) >205). These cut offs also identified patients who met a regulatory definition of remission. Specific objective end points for clinical improvement in two non-invasive indices and a quality of life instrument were determined with good sensitivity and specificity (SCCAI decrease >1.5, Seo decrease >30, IBDQ increase >20). Conclusions: We found specific cut off values for disease activity indices that identify patients who have significantly improved or achieved remission in an objective, sensitive, and specific manner. These cut offs should help in the interpretation of the outcomes of clinical trials in ulcerative colitis.
