Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Campusvej 55, 5230, Odense M, Denmark.
Chiropractic Knowledge Hub, Campusvej 55, 5230, Odense M, Denmark.
Health Qual Life Outcomes. 2021 Apr 9;19(1):116. doi: 10.1186/s12955-021-01758-0.
BACKGROUND: Currently, there are no outcome measures assessing the ability of people with non-specific low back pain to self-manage their illness. Inspired by the 'Patient Enablement Instrument', we developed the Patient Enablement Instrument for Back Pain (PEI-BP). The aim of this study was to describe the development of the Patient Enablement Instrument for Back Pain (PEI-BP) and investigate content validity, construct validity, internal consistency, test-retest reliability, measurement error, responsiveness and floor and ceiling effects. METHODS: The PEI-BP consists of 6 items that are rated on a 0-10 Numeric Rating Scale. Measurement properties were evaluated using the COSMIN taxonomy and were based on three cohorts from primary care with low back pain: The content validity cohort (N = 14) which participated in semi-structured interviews, the GLA:D® Back cohort (N = 272) and the test-retest cohort (N = 37) which both completed self-reported questionnaires. For construct validity and responsiveness, enablement was compared to disability (Oswestry Disability Index), back pain beliefs (Brief Illness Perception Questionnaire), fear avoidance (Fear-Avoidance Beliefs Questionnaire-physical activity), mental health (SF-36), educational level and number of previous episodes of low back pain. RESULTS: The PEI-BP was found to have acceptable content validity, construct validity, reliability (internal consistency, test-retest reliability and measurement error) and responsiveness. The Smallest Detectable Change was 10.1 points illustrating that a patient would have to change more than 1/6 of the scale range for it to be a true change. A skewed distribution towards the high scores were found at baseline indicating a potentially problematic ceiling effect in the current population. CONCLUSIONS: The PEI-BP can be considered a valid and reliable tool to measure enablement on people seeking care for non-specific LBP. Further testing of the PEI-BP in populations with more severe LBP is recommended. TRIAL REGISTRATION: Not applicable.
背景:目前,尚无评估非特异性腰痛患者自我管理疾病能力的结局测量工具。受“患者赋权工具”的启发,我们开发了腰痛患者赋权工具(PEI-BP)。本研究旨在描述腰痛患者赋权工具(PEI-BP)的开发过程,并考察其内容效度、结构效度、内部一致性、重测信度、测量误差、反应度以及界值效应和天花板效应。
方法:PEI-BP 由 6 个项目组成,每个项目均采用 0-10 的数字评定量表进行评分。采用 COSMIN 分类学评价测量学特性,研究对象来自初级保健的腰痛患者,包括:参与半结构式访谈的内容效度队列(n=14)、GLA:D®Back 队列(n=272)和完成自我报告问卷的重测队列(n=37)。为了考察结构效度和反应度,将赋权与残疾(Oswestry 残疾指数)、腰痛信念(简明疾病感知问卷)、恐惧回避(恐惧-回避信念问卷-体力活动)、心理健康(SF-36)、教育水平和腰痛发作次数进行比较。
结果:PEI-BP 具有可接受的内容效度、结构效度、信度(内部一致性、重测信度和测量误差)和反应度。最小可检测变化为 10.1 分,表明患者的量表评分变化超过 1/6 分才可能是真实变化。在基线时,高分的偏度分布表明当前人群可能存在潜在的天花板效应问题。
结论:PEI-BP 可作为一种评估非特异性腰痛患者赋权水平的有效、可靠工具。建议在腰痛更严重的人群中进一步测试 PEI-BP。
试验注册:不适用。
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