Wilkinson Thomas J, Nair Devika, Smith Alice C, Sohansoha Gurneet K, Ford Ella C, Vadaszy Noemi, Graham-Brown Matthew, Lightfoot Courtney J
NIHR Leicester Biomedical Research Center, University Hospitals of Leicester NHS Trust, Leicester General Hospital, Leicester, UK.
Leicester Diabetes Center, University of Leicester, University Hospitals of Leicester NHS Trust, Leicester General Hospital, Leicester, UK.
Kidney Int Rep. 2025 May 14;10(7):2275-2283. doi: 10.1016/j.ekir.2025.04.044. eCollection 2025 Jul.
Patient activation is the knowledge, skills, and confidence required to manage one's own health. In chronic kidney disease (CKD), the most frequently used measure of patient activation is the 13-item "Patient Activation Measure" (PAM-13). To help better determine an intervention's clinical effectiveness, trials can interpret changes in patient-derived outcomes using the "minimal clinically important difference" (MCID), defined as the smallest change important to the patient. In this study, we establish the MCID and minimal detectable change (MDC) for PAM-13 in patients with nondialysis CKD using established methodology.
This was a retrospective secondary analysis of a randomized control trial investigating the effects of a digital health intervention in a nondialysis CKD population. The MCID was estimated using anchor-based (using changes in health status from the Short Form-12 [SF-12] survey as the anchor) and distribution-based approaches (SD and effect size methods). The MDC was calculated to measure absolute reliability.
To calculate the MCID, we included = 136 participants (age: 61.7 ± 12.9, = 60 [44.1%] females, estimated glomerular filtration rate [eGFR]: 37.3 ± 14.9 ml/min per 1.73 m, and mean PAM-13 score: 62.6 ± 13.6). The MCID for the PAM-13 to maintain or improve health was estimated at 5.4 (± 12.1) (95% confidence interval [CI]: 3.4-7.4) points. The MDC of the PAM-13 at an individual level (MDC) was 7.2 points and at a group level (MDC) was 0.8 points.
These values should allow researchers and health care professionals to better interpret improvements from a patient's perspective and could be beneficial in determining whether changes in PAM-13 scores are clinically meaningful to a CKD population.
患者激活是管理自身健康所需的知识、技能和信心。在慢性肾脏病(CKD)中,最常用的患者激活测量方法是13项的“患者激活量表”(PAM - 13)。为了更好地确定干预措施的临床效果,试验可以使用“最小临床重要差异”(MCID)来解释患者衍生结局的变化,MCID定义为对患者而言重要的最小变化。在本研究中,我们使用既定方法确定非透析CKD患者PAM - 13的MCID和最小可检测变化(MDC)。
这是一项对随机对照试验的回顾性二次分析,该试验研究了数字健康干预对非透析CKD人群的影响。MCID采用基于锚定的方法(以简短健康调查问卷12项版[SF - 12]的健康状况变化为锚定)和基于分布的方法(标准差和效应量法)进行估计。计算MDC以测量绝对可靠性。
为计算MCID,我们纳入了n = 136名参与者(年龄:61.7±12.9,n = 60 [44.1%]为女性,估计肾小球滤过率[eGFR]:37.3±14.9 ml/min/1.73 m²,平均PAM - 13得分:62.6±13.6)。PAM - 13维持或改善健康的MCID估计为5.4(±12.1)(95%置信区间[CI]:3.4 - 7.4)分。PAM - 13在个体水平的MDC为7.2分,在组水平的MDC为0.8分。
这些值应能使研究人员和医疗保健专业人员从患者角度更好地解释改善情况,并有助于确定PAM - 13得分的变化对CKD人群是否具有临床意义。