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Pain relief that matters to patients: systematic review of empirical studies assessing the minimum clinically important difference in acute pain

机译:对患者而言至关重要的疼痛缓解:评估急性疼痛的最小临床重要差异的经验研究的系统评价

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BackgroundThe minimum clinically important difference (MCID) is used to interpret the clinical relevance of results reported by trials and meta-analyses as well as to plan sample sizes in new studies. However, there is a lack of consensus about the size of MCID in acute pain, which is a core symptom affecting patients across many clinical conditions. MethodsWe identified and systematically reviewed empirical studies of MCID in acute pain. We searched PubMed, EMBASE and Cochrane Library, and included prospective studies determining MCID using a patient-reported anchor and a one-dimensional pain scale (e.g. 100?mm visual analogue scale). We summarised results and explored reasons for heterogeneity applying meta-regression, subgroup analyses and individual patient data meta-analyses. ResultsWe included 37 studies (8479 patients). Thirty-five studies used a mean change approach, i.e. MCID was assessed as the mean difference in pain score among patients who reported a minimum degree of improvement, while seven studies used a threshold approach, i.e. MCID was assessed as the threshold in pain reduction associated with the best accuracy (sensitivity and specificity) for identifying improved patients. Meta-analyses found considerable heterogeneity between studies (absolute MCID: I2?=?93%, relative MCID: I2?=?75%) and results were therefore presented qualitatively, while analyses focused on exploring reasons for heterogeneity. The reported absolute MCID values ranged widely from 8 to 40?mm (standardised to a 100?mm scale) and the relative MCID values from 13% to 85%. From analyses of individual patient data (seven studies, 918 patients), we found baseline pain strongly associated with absolute, but not relative, MCID as patients with higher baseline pain needed larger pain reduction to perceive relief. Subgroup analyses showed that the definition of improved patients (one or several categories improvement or meaningful change) and the design of studies (single or multiple measurements) also influenced MCID values. ConclusionsThe MCID in acute pain varied greatly between studies and was influenced by baseline pain, definitions of improved patients and study design. MCID is context-specific and potentially misguiding if determined, applied or interpreted inappropriately. Explicit and conscientious reflections on the choice of a reference value are required when using MCID to classify research results as clinically important or trivial.
机译:背景最小临床重要差异(MCID)用于解释试验和荟萃分析报告的结果的临床相关性,并计划新研究中的样本量。但是,关于急性疼痛中MCID的大小尚无共识,这是影响许多临床病情患者的核心症状。方法我们确定并系统评价了MCID在急性疼痛中的经验研究。我们搜索了PubMed,EMBASE和Cochrane库,并纳入了前瞻性研究,这些研究使用患者报告的锚和一维疼痛量表(例如100?mm视觉模拟量表)确定MCID。我们总结了结果并探讨了应用荟萃回归,亚组分析和个别患者数据荟萃分析的异质性原因。结果我们纳入了37项研究(8479例患者)。 35项研究使用均值改变方法,即MCID被评估为报告最小改善程度的患者疼痛评分的平均差异,而七项研究使用阈值法,即MCID被评估为与疼痛减轻相关的阈值以最高的准确度(敏感性和特异性)来识别改善的患者。荟萃分析发现研究之间存在很大的异质性(绝对MCID:I 2 ?=?93%,相对MCID:I 2 ?=?75%),因此提出了结果定性地,而分析则集中在探索异质性的原因上。报告的绝对MCID值范围从8到40?mm(标准为100?mm刻度),相对MCID值从13%到85%。通过对单个患者数据的分析(七个研究,918例患者),我们发现基线疼痛与绝对(而非相对)MCID密切相关,因为基线疼痛较高的患者需要更大的疼痛缓解才能缓解。亚组分析表明,改善患者的定义(一个或多个类别改善或有意义的改变)和研究设计(单个或多个测量值)也影响了MCID值。结论急性疼痛的MCID在不同研究之间差异很大,并受基线疼痛,改善患者的定义和研究设计的影响。 MCID是特定于上下文的,如果确定,应用或解释不当,可能会造成误导。当使用MCID将研究结果归类为临床重要或琐碎的研究时,需要对参考值的选择进行明确而认真的思考。

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