Transdiagnostic Clinical Global Impression Scoring for Routine Clinical Settings

Boadie W Dunlop, Jaclyn Gray, Mark H Rapaport, Boadie W Dunlop, Jaclyn Gray, Mark H Rapaport

Abstract

Although there is great interest in the improving the ability to track patients' change over time in routine clinical care settings, no standardized transdiagnostic measure is currently available for busy clinicians to apply. The Clinical Global Impression (CGI) scales are simple measures widely used as outcomes in psychiatric clinical trials. However, the CGI suffers from poorly defined scoring anchors. Efforts to improve the anchors by enhancing the anchor descriptions have proven useful but are limited by being disease-specific, thereby acting as a barrier to the routine clinical adoption of the CGI. To inform the development of more broadly applicable CGI scoring anchors, we surveyed 24 clinical trial investigators, asking them to rank-order seven elements that inform their CGI-Severity (CGI-S) scoring. Symptom severity emerged as the most important element in determining CGI-S scores; the functional status of the patient emerged as a second element. Less importance was given to self-report symptom scores, staff observations, or side effects. Relative rankings of the elements' importance did not differ by investigators' experience nor time usually spent with patients. We integrated these results with published illness-specific CGI anchors to develop the Transdiagnostic CGI (T-CGI), which employs standardized scoring anchors applicable across psychiatric illnesses. Pending validity and reliability evaluations, the T-CGI may prove well-suited for inclusion in routine clinical settings and for incorporation into electronic medical records as a simple and useful measure of treatment efficacy.

Keywords: anxiety disorders; mood disorders; pharmacotherapy; psychotherapy; psychotic disorders; rating scale.

Conflict of interest statement

The authors declare no conflict of interest. Dunlop reports research funds from Assurex, Axsome, Bristol-Myers Squibb, GlaxoSmithKline, Janssen, National Institute of Mental Health, Otsuka, Pfizer, and Takeda. Dunlop has served as a paid consultant to Pfizer and Medavante. Gray reports no conflicts. Rapaport reports providing consulting services to PAX, Inc. (unpaid) and has been funded by the NIH.

Figures

Figure 1
Figure 1
Mean ranking of elements contributing to CGI-S scoring. For purposes of illustration, the scoring has been reversed so that more important elements are represented by higher scores. Vertical bars represent 95% CI.

References

    1. Trivedi M.H., Rush A.J., Crismon M.L., Kashner T.M., Toprac M.G., Carmody T.J., Key T., Biggs M.M., Shores-Wilson K., Witte B., et al. Clinical results for patients with major depressive disorder in the Texas Medication Algorithm Project. Arch. Gen. Psychiatry. 2004;61:669–680. doi: 10.1001/archpsyc.61.7.669.
    1. Bauer M., Pfennig A., Linden M., Smolka M.N., Neu P., Adli M. Efficacy of an algorithm-guided treatment compared with treatment as usual: A randomized, controlled study of inpatients with depression. J. Clin. Psychopharmacol. 2009;29:327–333. doi: 10.1097/JCP.0b013e3181ac4839.
    1. Guo T., Xiang Y.T., Xiao L., Hu C.Q., Chiu H.F., Ungvari G.S., Correll C.U., Lai K.Y., Feng L., Geng Y., et al. Measurement-based care versus standard care for major depression: A randomized controlled trial with blind raters. Am. J. Psychiatry. 2015;172:1004–1013. doi: 10.1176/appi.ajp.2015.14050652.
    1. Zimmerman M., McGlinchey J.B. Why don’t psychiatrists use scales to measure outcome when treating depressed patients? J. Clin. Psychiatry. 2008;68:1916–1919. doi: 10.4088/JCP.v69n1209.
    1. Hatfield D.R., Ogles B.M. Why some clinicians use outcome measures and others do not. Adm. Policy Ment. Health. 2007;34:283–291. doi: 10.1007/s10488-006-0110-y.
    1. Bech P. Rating scales in depression: Limitations and pitfalls. Dialogues Clin. Neurosci. 2006;8:207–215.
    1. Correll C.U., Kishimoto T., Kane J.M. Randomized controlled trials in schizophrenia: Opportunities, limitations, and trial design alternatives. Dialogues Clin. Neurosci. 2011;13:155–172.
    1. Mortimer A.M. Symptom rating scales and outcome in schizophrenia. Br. J. Psychiatry. 2007;191:s7–s14. doi: 10.1192/bjp.191.50.s7.
    1. Cohen R.M., Greenberg J.M., IsHak W.W. Incorporating multidimensional patient-reported outcomes of symptom severity, functioning, and quality of life in the Individual Burden of Illness Index for Depression to measure treatment impact and recovery in MDD. JAMA Psychiatry. 2013;70:343–350. doi: 10.1001/jamapsychiatry.2013.286.
    1. Rapaport M.H., Clary C., Fayyad R., Endicott J. Quality-of-life impairment in depressive and anxiety disorders. Am. J. Psychiatry. 2005;162:1171–1178. doi: 10.1176/appi.ajp.162.6.1171.
    1. Sheehan D.V., Harnett-Sheehan K., Raj B.A. The measurement of disability. Int. Clin. Psychopharmacol. 1996;11(Suppl. 3):89–95. doi: 10.1097/00004850-199606003-00015.
    1. Lin C.H., Chou L.S., Chen M.C., Chen C.C. The relationship between symptom relief and functional improvement during acute fluoxetine treatment for patients with major depressive disorder. J. Affect. Disord. 2015;182:115–120. doi: 10.1016/j.jad.2015.04.022.
    1. Frisch M.B., Cornell J., Villanueva M., Retzlaff P.J. Clinical validation of the Quality of Life Inventory: A measure of life satisfaction for use in treatment planning and outcome assessment. Psychol. Assess. 1992;4:92–101. doi: 10.1037/1040-3590.4.1.92.
    1. Guy W. In: ECDEU Assessment Manual for Psychopharmacology, Revised Edition. Guy W., editor. NIMH Publication; Rockville, MD, USA: 1976. pp. 217–222.
    1. Nierenberg A.A., DeCecco L.M. Definitions of antidepressant treatment response, remission, nonresponse, partial response, and other relevant outcomes: A focus on treatment-resistant depression. J. Clin. Psychiatry. 2001;62(Suppl. 16):5–9.
    1. Shear M.K., Vanderbilt J., Rucci P., Endicott J., Lydiard B., Otto M.W., Pollack M.H., Chandler L., Williams J., Ali A., et al. Reliability and validity of a structured interview guide for the Hamilton Anxiety Rating Scale (SIGH-A) Depress. Anxiety. 2001;13:166–178. doi: 10.1002/da.1033.
    1. Williams J.B.W., Kobak K.A. Development and Reliability of the SIGMA: A structured interview guide for the Montgomery-Asberg Depression Rating Scale (MADRS) Br. J. Psychiatry. 2008;192:52–58. doi: 10.1192/bjp.bp.106.032532.
    1. Zanello A., Berthoud L., Ventura J., Merlo M.C.G. The Brief Psychiatric Rating Scale (version 4.0) factorial structure and its sensitivity in the treatment of outpatients with unipolar depression. Psychiatry Res. 2013;210:626–633. doi: 10.1016/j.psychres.2013.07.001.
    1. Liebowitz M.R., Gorman J.M., Fyer A.J., Campeas R., Levin A.P., Sandberg D., Hollander E., Papp L., Goetz D. Pharmacotherapy of social phobia: An interim report of a placebo-controlled comparison of phenelzine and atenolol. J. Clin. Psychiatry. 1988;49:252–257. doi: 10.1016/S0033-3182(87)72520-1.
    1. Spearing M.K., Post R.M., Leverich G.S., Brandt D., Nolen W. Modification of the Clinical Global Impressions (CGI) scale for use in bipolar illness (BP): The CGI-BP. Psychiatry Res. 1997;73:159–171. doi: 10.1016/S0165-1781(97)00123-6.
    1. Haro J.M., Kamath S.A., Ochoa S., Novick D., Rele K., Fargas A., Rodriguez M.J., Rele R., Orta J., Kharbeng A., et al. The Clinical Global Impression–Schizophrenia scale: A simple instrument to measure the diversity of symptoms present in schizophrenia. Acta Psychiatr. Scand. 2003;107(Suppl. 416):16–23. doi: 10.1034/j.1600-0447.107.s416.5.x.
    1. Salzmann E., Robin J.L. Multicentric double-blind study comparing efficacy and safety of minaprine and imipramine in dysthymic disorders. Neuropsychobiology. 1995;31:68–75. doi: 10.1159/000119175.
    1. Targum S.D., Hassman H., Pinho M., Fava M. Development of a clinical global impression scale for fatigue. J. Psychiatr. Res. 2012;46:370–374. doi: 10.1016/j.jpsychires.2011.12.001.
    1. Malow B.A., Connolly H.V., Weiss S.K., Halbower A., Goldman S., Hyman S.L., Katz T., Madduri N., Shui A., Macklin E., et al. The Pediatric Sleep Clinical Global Impressions Scale—A new Tool to measure pediatric insomnia in autism spectrum disorders. J. Dev. Behav. Pediatr. 2016;37:370–376. doi: 10.1097/DBP.0000000000000307.
    1. Shear K., Frank E., Houck P.R., Reynolds C.F. Treatment of complicated grief. A randomized controlled trial. JAMA Psychiatry. 2014;71:1287–1295. doi: 10.1001/jamapsychiatry.2014.1242.
    1. Shear M.K., Reynolds C.F., III, Simon N.M., Zisook S., Wang Y., Mauro C., Duan N., Lebowitz B., Skritskaya N. Optimizing treatment of complicated grief: A randomized clinical trial. JAMA Psychiatry. 2016;73:685–694. doi: 10.1001/jamapsychiatry.2016.0892.
    1. Glassman A.H., O’Connor C.M., Califf R.M., Swedberg K., Schwartz P., Bigger J.T., Jr., Krishnan K.R., van Zyl L.T., Swenson J.R., Finkel M.S., et al. Sertraline Antidepressant Heart Attack Randomized Trial (SADHEART) Group. Sertraline treatment of major depression in patients with acute MI or unstable angina. J. Am. Med. Assoc. 2002;288:701–709. doi: 10.1001/jama.288.6.701.
    1. Dahlke F., Lohaus A., Gutzmann H. Reliability and clinical concepts underlying global judgments in dementia: Implications for clinical research. Psychopharmacol. Bull. 1992;28:425–432.
    1. Weitkunat R., Letzel H., Kanowski S., Grobe-Einsler R. Clinical and psychometric evaluation of the efficacy of nootropic drugs: Characteristics of several procedures. Zeitschrift für Gerontopsychologie und-Psychiatrie. 1993;6:51–60.
    1. Beneke M., Rasmus W. “Clinical Global Impressions” (ECDEU): Some Critical Comments. Pharmacopsychiatry. 1992;25:171–176. doi: 10.1055/s-2007-1014401.
    1. Leon A.C., Shear M.K., Klerman G.L., Portera L., Rosenbaum J.F., Goldenberg I.A. Comparison of symptom determinants of patient and clinician global ratings in patients with panic disorder and depression. J. Clin. Psychopharmacol. 1993;13:327–331. doi: 10.1097/00004714-199310000-00005.
    1. Spielmans G.I., McFall J.P. A comparative meta-analysis of Clinical Global Impressions change in antidepressant trials. J. Nerv. Ment. Dis. 2006;194:845–852. doi: 10.1097/01.nmd.0000244554.91259.27.
    1. Zaider T.I., Heimberg R.G., Fresco D.M., Schneier F.R., Liebowitz M.R. Evaluation of the Clinical Global Impression Scale among individuals with social anxiety disorder. Psychol. Med. 2003;33:611–622. doi: 10.1017/S0033291703007414.
    1. Brady K., Pearlstein T., Asnis G.M., Baker D., Rothbaum B., Sikes C.R., Farfel G.M. Efficacy and safety of sertraline treatment of posttraumatic stress disorder: A randomized controlled trial. J. Am. Med. Assoc. 2000;283:1837–1844. doi: 10.1001/jama.283.14.1837.
    1. Barlow D.H., Gorman J.M., Shear M.K., Woods S.W. Cognitive-behavioral therapy, imipramine, or their combination for panic disorder: A randomized controlled trial. J. Am. Med. Assoc. 2000;283:2529–2536. doi: 10.1001/jama.283.19.2529.
    1. Hudson J.I., McElroy S.L., Raymond N.C., Crow S., Keck P.E., Jr., Carter W.P., Mitchell J.E., Strakowski S.M., Pope H.G., Jr., Coleman B.S., et al. Fluvoxamine in the treatment of binge-eating disorder: A multicenter placebo-controlled, double-blind trial. Am. J. Psychiatry. 1998;155:1756–1762. doi: 10.1176/ajp.155.12.1756.
    1. Targum S.D., Houser C., Northcutt J., Little J.A., Cutler A.J., Walling D.P. A structured interview guide for global impressions: Increasing reliability and scoring accuracy for CNS trials. Ann. Gen. Psychiatry. 2013;12:2. doi: 10.1186/1744-859X-12-2.
    1. Forkmann T., Scherer A., Boecker M., Pawelzik M., Jostes R., Gauggel S. The clinical global impression scale and the influence of patient or staff perspective on outcome. BMC Psychiatry. 2011;11:83. doi: 10.1186/1471-244X-11-83.
    1. Leucht S., Engel R.R. The relative sensitivity of the Clinical Global Impressions Scale and the Brief Psychiatric Rating Scale in antipsychotic drug trials. Neuropsychopharmacology. 2006;31:406–412. doi: 10.1038/sj.npp.1300873.
    1. Harding K.J., Rush A.J., Arbuckle M., Trivedi M.H., Pincus H.A. Measurement-based care in psychiatric practice: A policy framework for implementation. J. Clin. Psychiatry. 2011;72:1136–1143. doi: 10.4088/JCP.10r06282whi.
    1. Fortney J.C., Unützer J., Wrenn G., Pyne J.M., Smith G.R., Schoenbaum M., Harbin H.T. A tipping point for measurement-based care. Psychiatry Serv. 2017;68:179–188. doi: 10.1176/appi.ps.201500439.
    1. Institute of Medicine . Toward Quality Measures for Population Health and the Leading Health Indicators. The National Academies Press; Washington, DC, USA: 2012.
    1. Kilbourne A.M., Keyser D., Pincus H.A. Challenges and opportunities in measuring the quality of mental health care. Can. J. Psychiatry. 2010;55:549–557. doi: 10.1177/070674371005500903.
    1. Lee T.-S., Nkouibert Assam P., Gersing K.R., Chan E., Burchett B.M., Sim K., Feng L., Krishnan K.R., Rush A.J. The Effectiveness of antidepressant monotherapy in a naturalistic outpatient setting. Prim. Care Companion CNS Disord. 2012;14:PCC.12m01364. doi: 10.4088/PCC.12m01364.
    1. Khan A., Brodhead A.E., Kolts R.L. Relative sensitivity of the Montgomery-Asberg depression rating scale, the Hamilton depression rating scale and the Clinical Global Impressions rating scale in antidepressant clinical trials: A replication analysis. Int. Clin. Psychopharmacol. 2004;19:157–160. doi: 10.1097/00004850-200405000-00006.
    1. Reimherr F.W., Chouinard G., Cohn C.K., Cole J.O., Itil T.M., LaPieree Y.D., Masco H.L., Mendels J. Antidepressant efficacy of sertraline: A double-blind, placebo- and amitriptyline-controlled, multicenter comparison study in outpatients with major depression. J. Clin. Psychiatry. 1990;51(Suppl. B):18–27.
    1. Targum S.D., Busner J., Young A.H. Targeted scoring criteria reduce variance in global impressions. Hum. Psychopharmacol. 2008;23:629–633. doi: 10.1002/hup.966.
    1. Busner J., Targum S.D. The Clinical Global Impressions Scale: Applying a research tool in clinical practice. Psychiatry (Edgmont) 2007;4:28–37.

Source: PubMed

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