PMID- 28215182 OWN - NLM STAT- MEDLINE DCOM- 20170524 LR - 20181202 IS - 1741-7015 (Electronic) IS - 1741-7015 (Linking) VI - 15 IP - 1 DP - 2017 Feb 20 TI - Pain relief that matters to patients: systematic review of empirical studies assessing the minimum clinically important difference in acute pain. PG - 35 LID - 10.1186/s12916-016-0775-3 [doi] LID - 35 AB - 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(2) = 93%, relative MCID: I(2) = 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. FAU - Olsen, Mette Frahm AU - Olsen MF AUID- ORCID: 0000-0002-5742-6403 AD - Nordic Cochrane Centre, Rigshospitalet, Blegdamsvej 9, Department 7811, 2100, Copenhagen O, Denmark. FAU - Bjerre, Eik AU - Bjerre E AD - University Hospitals' Centre for Health Research (UCSF), Rigshospitalet, Blegdamsvej 9, Department 9701, 2100, Copenhagen O, Denmark. FAU - Hansen, Maria Damkjaer AU - Hansen MD AD - Frederiksberg Hospital, Nordre Fasanvej 57, 2000, Frederiksberg, Denmark. FAU - Hilden, Jorgen AU - Hilden J AD - Section of Biostatistics, University of Copenhagen, Ostre Farigmagsgade 5, 114, Copenhagen O, Denmark. FAU - Landler, Nino Emanuel AU - Landler NE AD - Department of Cardiology, Herlev-Gentofte Hospital, Kildegardsvej 28, 2900, Hellerup, Denmark. FAU - Tendal, Britta AU - Tendal B AD - Nordic Cochrane Centre, Rigshospitalet, Blegdamsvej 9, Department 7811, 2100, Copenhagen O, Denmark. FAU - Hrobjartsson, Asbjorn AU - Hrobjartsson A AD - Centre for Evidence-Based Medicine, University of Southern Denmark & Odense University Hospital, Sdr. Boulevard 29, Gate 50 (Videncenteret), 5000, Odense C, Denmark. Asbjorn.Hrobjartsson@rsyd.dk. LA - eng PT - Journal Article PT - Review PT - Systematic Review DEP - 20170220 PL - England TA - BMC Med JT - BMC medicine JID - 101190723 SB - IM MH - Acute Pain/*therapy MH - Adolescent MH - Adult MH - Aged MH - Disability Evaluation MH - Humans MH - Middle Aged MH - Pain Management/*methods MH - Young Adult PMC - PMC5317055 OTO - NOTNLM OT - Minimum clinically important difference OT - Pain OT - Systematic review EDAT- 2017/02/22 06:00 MHDA- 2017/05/26 06:00 PMCR- 2017/02/20 CRDT- 2017/02/21 06:00 PHST- 2016/08/27 00:00 [received] PHST- 2016/12/23 00:00 [accepted] PHST- 2017/02/21 06:00 [entrez] PHST- 2017/02/22 06:00 [pubmed] PHST- 2017/05/26 06:00 [medline] PHST- 2017/02/20 00:00 [pmc-release] AID - 10.1186/s12916-016-0775-3 [pii] AID - 775 [pii] AID - 10.1186/s12916-016-0775-3 [doi] PST - epublish SO - BMC Med. 2017 Feb 20;15(1):35. doi: 10.1186/s12916-016-0775-3.