Minimum clinically important differences identified for commonly used depression rating scales
2013; Elsevier BV; Volume: 66; Issue: 7 Linguagem: Inglês
10.1016/j.jclinepi.2013.01.010
ISSN1878-5921
Autores Tópico(s)Mental Health Research Topics
ResumoThere are many treatments for depression, and clinicians face the difficult challenge of determining the relative differences between them based on literature using rating scales developed largely for research purposes. Response to therapy is often defined as a reduction of ≥50% from the baseline score [1Duru G. Fantino B. The clinical relevance of changes in the Montgomery-Asberg Depression Rating Scale using the minimum clinically important difference approach.Curr Med Res Opin. 2008; 24: 1329-1335Crossref PubMed Scopus (74) Google Scholar, 2Hawley C.J. Gale T.M. Sivakumaran T. Defining remission by cut off score on the MADRS: selecting the optimal value.J Affect Disord. 2002; 72: 177-184Abstract Full Text Full Text PDF PubMed Scopus (189) Google Scholar]. Reliance on this arbitrary value negates small changes, which may be relevant in individual patients [[1]Duru G. Fantino B. The clinical relevance of changes in the Montgomery-Asberg Depression Rating Scale using the minimum clinically important difference approach.Curr Med Res Opin. 2008; 24: 1329-1335Crossref PubMed Scopus (74) Google Scholar]. The National Institute for Health and Clinical Excellence guidelines for depression cite a three-point change as being clinically relevant for the Hamilton depression rating scale (Ham-D) and Beck Depression Inventory (BDI) but do not reference this value [[3]Clinical Practice Guideline (no 23)Depression: management of depression in primary and secondary care [Internet]. National Institute for Clinical Excellence, London2004http://www.nice.org.uk/nicemedia/pdf/cg023fullguideline.pdfGoogle Scholar]. However, two recent meta-analyses examining the preexisting clinical trial data found that the difference in response between treatment and placebo does not meet this three-point threshold even in cases of severe depression [4Fournier J.C. DeRubeis R.J. Hollon S.D. et al.Antidepressant drug effects and depression severity: a patient-level meta-analysis.JAMA. 2010; 303: 47-53Crossref PubMed Scopus (1536) Google Scholar, 5Kirsch I. Deacon B.J. Huedo-Medina T.B. et al.Initial severity and antidepressant benefits: a meta-analysis of data submitted to the Food and Drug Administration.PLoS Med. 2008; 5: e45Crossref PubMed Scopus (1867) Google Scholar]. The minimum clinically important difference (MCID) is defined as the minimum change in a measurable outcome in which the patient perceives a difference because of a therapy/intervention [1Duru G. Fantino B. The clinical relevance of changes in the Montgomery-Asberg Depression Rating Scale using the minimum clinically important difference approach.Curr Med Res Opin. 2008; 24: 1329-1335Crossref PubMed Scopus (74) Google Scholar, 6Wilson H.D. Minimum clinical important differences of health outcomes in a chronic pain population: are they predictive of poor outcomes?.Dissertation Abstr Int Section B: Sci Eng. 2008; 68: 8435Google Scholar]. We performed a systematic search for articles that identified the MCID of the following scales: BDI, Geriatric Depression Scale (GDS), Ham-D, Montgomery–Asberg Depression Rating Scale (MADRS), and Quick Inventory of Depressive Symptomatology (QIDS). These scales were chosen following solicited advice from several clinicians working in psychiatry. We searched PubMed, EMBASE, and PsycINFO databases up to March 2012. Permutations of “MCID” and clinical relevance were searched. No language, population, dates, or study design restrictions were used. Seven studies were included (see Table 1 and Appendix 1): 3 for BDI [6Wilson H.D. Minimum clinical important differences of health outcomes in a chronic pain population: are they predictive of poor outcomes?.Dissertation Abstr Int Section B: Sci Eng. 2008; 68: 8435Google Scholar, 7Dworkin R.H. Turk D.C. Wyrwich K.W. et al.Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations.J Pain. 2008; 9: 105-121Abstract Full Text Full Text PDF PubMed Scopus (2332) Google Scholar, 8Hiroe T. Kojima M. Yamamoto I. et al.Gradations of clinical severity and sensitivity to change assessed with the Beck Depression Inventory-II in Japanese patients with depression.Psychiatry Res. 2005; 135: 229-235Abstract Full Text Full Text PDF PubMed Scopus (126) Google Scholar], 3 for MADRS [1Duru G. Fantino B. The clinical relevance of changes in the Montgomery-Asberg Depression Rating Scale using the minimum clinically important difference approach.Curr Med Res Opin. 2008; 24: 1329-1335Crossref PubMed Scopus (74) Google Scholar, 2Hawley C.J. Gale T.M. Sivakumaran T. Defining remission by cut off score on the MADRS: selecting the optimal value.J Affect Disord. 2002; 72: 177-184Abstract Full Text Full Text PDF PubMed Scopus (189) Google Scholar, 9Bandelow B. Baldwin D.S. Dolbert O.T. et al.What is the threshold for symptomatic response and remission for major depressive disorder, panic disorder, social anxiety disorder, and generalized anxiety disorder?.J Clin Psychiatry. 2006; 67: 1428-1434Crossref PubMed Scopus (176) Google Scholar] and 1 for QIDS and Ham-D [[10]Rush A.J. Trivedi M.H. Ibrahim H.M. et al.The 16-item quick inventory of depressive symptomatology (QIDS), clinical rating (QIDS-C), and self-report (QIDS-SR): a psychometric evaluation in patients with chronic major depression.Biol Psychiatry. 2003; 54: 573-583Abstract Full Text Full Text PDF PubMed Scopus (2730) Google Scholar]. No MCID information was found for GDS. One study identified the MCID for MADRS to be a 1.6- to 1.9-point change from baseline [[1]Duru G. Fantino B. The clinical relevance of changes in the Montgomery-Asberg Depression Rating Scale using the minimum clinically important difference approach.Curr Med Res Opin. 2008; 24: 1329-1335Crossref PubMed Scopus (74) Google Scholar], and another identified the remission cut off as a total score of 5 is clinically significant, although smaller changes should be considered for minimally important differencesHawley et al. [2]Hawley C.J. Gale T.M. Sivakumaran T. Defining remission by cut off score on the MADRS: selecting the optimal value.J Affect Disord. 2002; 72: 177-184Abstract Full Text Full Text PDF PubMed Scopus (189) Google Scholar684 MDD patients partaking in clinical trialsMADRSAnchor-based methodMisclassification: <8 or <10 (<9 ideal with lowest number of misclassifications)Borderline distribution: <10Combined: <9 and <10 are the optimal cut off scores for remissionHiroe et al. [8]Hiroe T. Kojima M. Yamamoto I. et al.Gradations of clinical severity and sensitivity to change assessed with the Beck Depression Inventory-II in Japanese patients with depression.Psychiatry Res. 2005; 135: 229-235Abstract Full Text Full Text PDF PubMed Scopus (126) Google Scholar85 MDD patients (single or recurrent episode as defined by DSM-IV); JapaneseBDI-IIAnchor-based methodMCID = 5 (0–9, no or slight change; 10–19, moderate change; and ≥20, large change)Wilson [6]Wilson H.D. Minimum clinical important differences of health outcomes in a chronic pain population: are they predictive of poor outcomes?.Dissertation Abstr Int Section B: Sci Eng. 2008; 68: 8435Google ScholarA total of 2,804 patients. (n = 1,976 in training set and n = 828 in test set)BDIAnchor- and distribution-based methodsMCID = 29.64% reduction from baseline scoreBandelow et al. [9]Bandelow B. Baldwin D.S. Dolbert O.T. et al.What is the threshold for symptomatic response and remission for major depressive disorder, panic disorder, social anxiety disorder, and generalized anxiety disorder?.J Clin Psychiatry. 2006; 67: 1428-1434Crossref PubMed Scopus (176) Google Scholar5 RCTs in patients with MDD all esicatolpram vs. placeboMADRSAnchor-based methodMADRS ≤5 equals complete or symptom-free remission (CGI-S = 1)MADRS ≤11 equals remission (CGI-S <2)Rush et al. [10]Rush A.J. Trivedi M.H. Ibrahim H.M. et al.The 16-item quick inventory of depressive symptomatology (QIDS), clinical rating (QIDS-C), and self-report (QIDS-SR): a psychometric evaluation in patients with chronic major depression.Biol Psychiatry. 2003; 54: 573-583Abstract Full Text Full Text PDF PubMed Scopus (2730) Google ScholarData from 681 adult nonpsychotic MDD patients. Subjects were randomly assigned to 12 wk of acute-phase outpatient treatment with nefazodone, CBASP, or their combination.Outcomes were obtained by self-reports and clinical raters blind to treatment assignmentQIDS-SR (16-item, self-reported)Ham-D (17-, 21-, and 24-item versions)Anchor-based methodPGI-I minimally improved = QIDS-SR of ≥28.5% ± 28.7% changeHam-D17 of ≥27.1% ± 25.7% changeHam-D21 of ≥27% ± 25.1% changeHam-D24 of ≥28% ± 25.2% changeAbbreviations: DSM-IV, Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition; MADRS, Montgomery–Asberg Depression Rating Scale; MCID, minimum clinically important difference; BDI, Beck Depression Inventory; MDD, major depressive disorder; RCT, randomized controlled trial; CGI, clinical global impression; MITT, Modified Intention-to-treat; LOCF, last observation carried forward; CBASP, Cognitive Behavioral Analysis System of Psychotherapy; QIDS-SR16, Quick Inventory of Depressive Symptomatology. Open table in a new tab Abbreviations: DSM-IV, Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition; MADRS, Montgomery–Asberg Depression Rating Scale; MCID, minimum clinically important difference; BDI, Beck Depression Inventory; MDD, major depressive disorder; RCT, randomized controlled trial; CGI, clinical global impression; MITT, Modified Intention-to-treat; LOCF, last observation carried forward; CBASP, Cognitive Behavioral Analysis System of Psychotherapy; QIDS-SR16, Quick Inventory of Depressive Symptomatology. We encourage clinicians to use this information as a part of their decision-making process when choosing therapies for patients with depression. We feel that more studies should be conducted using accepted methods for calculating MCID values and believe that clinical trial researchers should feel obliged to include these analyses in their published reports. We urge clinicians to educate themselves in the area of clinical importance and look for and understand these fundamental concepts when reviewing the literature. Download .doc (.04 MB) Help with doc files Appendix
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