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

AI Article Synopsis

  • - The study investigates the minimum clinically important difference (MCID) for acute pain, which is crucial for understanding clinical trial results, but there isn't a universal agreement on what the MCID value should be due to its varying nature across studies.
  • - Researchers reviewed 37 studies with nearly 8,500 patients, examining both a mean change approach and a threshold approach to determine MCID, uncovering significant variability in reported values, which ranged from 8 to 40 mm on a 100 mm pain scale.
  • - They found that higher baseline pain levels correlated with needing a larger pain reduction to feel an improvement, signaling the complexity of defining clinically meaningful changes in pain management.

Article Abstract

Background: The 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.

Methods: We 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.

Results: We 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: I = 93%, relative MCID: I = 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.

Conclusions: The 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.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5317055PMC
http://dx.doi.org/10.1186/s12916-016-0775-3DOI Listing

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