评估随时间推移的健康状况：回顾期和锚定问题对 COPD 健康状况工具的最小临床重要差异的影响。
Assessing health status over time: impact of recall period and anchor question on the minimal clinically important difference of copd health status tools.
机构信息
University of Groningen, University Medical Center Groningen, Department of General Practice and Elderly Care Medicine, HPC FA21, Postbox 196, NL-9700, AD, Groningen, The Netherlands.
University of Groningen, University Medical Center Groningen, Groningen Research Institute for Asthma and COPD (GRIAC), Groningen, The Netherlands.
出版信息
Health Qual Life Outcomes. 2018 Jun 26;16(1):130. doi: 10.1186/s12955-018-0950-7.
BACKGROUND
The Minimal Clinically Important Difference (MCID) assesses what change on a measurement tool can be considered minimal clinically relevant. Although the recall period can influence questionnaire scores, it is unclear if it influences the MCID. This study is the first to examine longitudinally the impact of the recall period of an anchor question and its design on the MCID of COPD health status tools using the COPD Assessment Test (CAT), Clinical COPD Questionnaire (CCQ) and the St. George's Respiratory Questionnaire (SGRQ).
METHODS
Moderate to very severe COPD patients without respiratory co-morbidities were recruited during 3-week Pulmonary Rehabilitation (PR). CAT, CCQ and SGRQ were completed at baseline, discharge, 3, 6, 9 and 12 months. A 15-point Global Rating of Change scale (GRC) was completed at each follow-up. A five-point GRC was used as second anchor at 12 months. Mean change scores of a subset of patients indicating a minimal improvement on each of the anchor questions were considered the MCID. The MCID estimates over different time periods were compared with one another by evaluating the degree of overlap of Confidence Intervals (CI) adjusted for dependency.
RESULTS
In total 451 patients were included (57.9 ± 6.6 years, 65% male, 50/39/11% GOLD II/III/IV), of which 309 completed follow-up. Baseline health status scores were 20.2 ± 7.3 (CAT), 2.9 ± 1.2 (CCQ) and 50.7 ± 17.3 (SGRQ). MCID estimates for improvement ranged - 3.1 to - 1.4 for CAT, - 0.6 to - 0.3 for CCQ, and - 10.3 to - 7.6 for SGRQ. Absolute higher - though not significant - MCIDs were observed for CAT and CCQ directly after PR. Significantly absolute lower MCID estimates were observed for CAT (difference - 1.4: CI -2.3 to - 0.5) and CCQ (difference - 0.2: CI -0.3 to -0.1) using a five-point GRC.
CONCLUSIONS
The recall period of a 15-point anchor question seemed to have limited impact on the MCID for improvement of CAT, CCQ and SGRQ during PR; although a 3-week MCID estimate directly after PR might lead to absolute higher values. However, the design of the anchor question was likely to influence the MCID of CAT and CCQ.
TRIAL REGISTRATION
RIMTCORE trial # DRKS00004609 and #12107 (Ethik-Kommission der Bayerischen Landesärztekammer).
背景
最小临床重要差异 (MCID) 评估了测量工具上的何种变化可被视为最小临床相关。尽管回忆期可能会影响问卷评分，但它是否会影响 MCID 尚不清楚。这项研究首次使用 COPD 评估测试 (CAT)、临床 COPD 问卷 (CCQ) 和圣乔治呼吸问卷 (SGRQ)，从纵向角度检查了锚定问题的回忆期及其设计对 COPD 健康状况工具的 MCID 的影响。
方法
在为期 3 周的肺康复 (PR) 期间招募无呼吸合并症的中重度至极重度 COPD 患者。在基线、出院时、第 3、6、9 和 12 个月时完成 CAT、CCQ 和 SGRQ。在每次随访时完成 15 分的整体变化评分 (GRC)。在第 12 个月使用 5 分 GRC 作为第二个锚定。考虑到依赖关系，将每个锚定问题中表示最小改善的患者的平均变化评分子集被视为 MCID。通过评估调整后的置信区间 (CI) 重叠程度，比较不同时间段的 MCID 估计值。
结果
共纳入 451 名患者 (57.9±6.6 岁，65%为男性，GOLD II/III/IV 分别为 50/39/11%)，其中 309 名完成了随访。基线健康状况评分为 20.2±7.3 (CAT)、2.9±1.2 (CCQ) 和 50.7±17.3 (SGRQ)。CAT、CCQ 和 SGRQ 的改善 MCID 估计值范围分别为-3.1 至-1.4、-0.6 至-0.3 和-10.3 至-7.6。PR 后直接观察到 CAT 和 CCQ 的 MCID 绝对值更高，但无统计学意义。使用 5 分 GRC，CAT 和 CCQ 的 MCID 估计值明显更低，差异分别为-1.4(CI-2.3 至-0.5)和-0.2(CI-0.3 至-0.1)。
结论
15 分锚定问题的回忆期似乎对 PR 期间 CAT、CCQ 和 SGRQ 的改善 MCID 影响有限；尽管 PR 后 3 周的 MCID 估计值可能导致绝对值更高。然而，锚定问题的设计可能会影响 CAT 和 CCQ 的 MCID。
试验注册
RIMTCORE 试验#DRKS00004609 和#12107（巴伐利亚州立医师协会伦理委员会）。
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