MIMIC Model of the CES-D.

<p>MIMIC Model of the CES-D.</p

Factor loadings for the “Positive” and “Negative” latent factors of the CES-D and influence on the overall estimates of fatigue latent factor scores.

a<p>Not corrected for DIF.</p>b<p>^bCorrected for DIF for items 3, 10, and 11.</p><p>CI = Confidence Interval.</p

An Assessment of the Measurement Equivalence of English and French Versions of the Center for Epidemiologic Studies Depression (CES-D) Scale in Systemic Sclerosis

<div><p>Objectives</p><p>Center for Epidemiologic Studies Depression (CES-D) Scale scores in English- and French-speaking Canadian systemic sclerosis (SSc) patients are commonly pooled in analyses, but no studies have evaluated the metric equivalence of the English and French CES-D. The study objective was to examine the metric equivalence of the CES-D in English- and French-speaking SSc patients.</p><p>Methods</p><p>The CES-D was completed by 1007 English-speaking and 248 French-speaking patients from the Canadian Scleroderma Research Group Registry. Confirmatory factor analysis (CFA) was used to assess the factor structure in both samples. The Multiple-Indicator Multiple-Cause (MIMIC) model was utilized to assess differential item functioning (DIF).</p><p>Results</p><p>A two-factor model (Positive and Negative affect) showed excellent fit in both samples. Statistically significant, but small-magnitude, DIF was found for 3 of 20 CES-D items, including items 3 (<i>Blues</i>), 10 (<i>Fearful</i>), and 11 (<i>Sleep</i>). Prior to accounting for DIF, French-speaking patients had 0.08 of a standard deviation (SD) lower latent scores for the Positive factor (95% confidence interval [CI]−0.25 to 0.08) and 0.09 SD higher scores (95% CI−0.07 to 0.24) for the Negative factor than English-speaking patients. After DIF correction, there was no change on the Positive factor and a non-significant increase of 0.04 SD on the Negative factor for French-speaking patients (difference = 0.13 SD, 95% CI−0.03 to 0.28).</p><p>Conclusions</p><p>The English and French versions of the CES-D, despite minor DIF on several items, are substantively equivalent and can be used in studies that combine data from English- and French-speaking Canadian SSc patients.</p></div

Sociodemographic and Disease-Related Characteristics.

<p>Due to missing values:</p>a<p>^an = 1005;</p>b<p>^bn = 1003;</p>c<p>^cn = 1004;</p>d<p>^dn = 992;</p>e<p>^en = 247;</p>f<p>^fn = 991; and ^gn = 243.</p

Comparison of BDI-II Somatic Symptom Scores for Female Patients Versus Male Patients.

<p>BDI-II = Beck Depression Inventory-II.</p>1<p>Definitions of cognitive/affective and somatic scores in text.</p

Comparison of BDI-II Somatic Symptom Item Scores for Female Patients Versus Male Patients.

<p>BDI-II = Beck Depression Inventory-II.</p>1<p>Definition of somatic scores in text.</p>2<p>Statistically significant based on Hochberg's Sequential Method.</p

PRISMA Flow Diagram of Study Selection Process for Key Question #1.

<p>PRISMA Flow Diagram of Study Selection Process for Key Question #1.</p

Characteristics of Studies of Diagnostic Accuracy.

*<p>Corrected diagnostic accuracy data were provided in a subsequent erratum (Frasure-Smith N, Lesperance F, Talajic M. Depression after myocardial infarction: Response. <i>Circulation</i>. 1998; 97: 707–708).</p>†<p>The modified DIS did not require that symptoms be of at least 2 weeks duration and did not apply the criteria of seeking medical help and experiencing impairment.</p>‡<p>Mean age based on full study sample of 682 patients, rather than the 613 patients included in the analyses reported in the table.</p>§<p>The depression section of the modified DIS starts with somatic rather than cognitive or mood-related symptoms and focuses on current rather than lifetime symptoms.</p>∥<p>Patients met the “PHQ diagnosis” if they reported a total of 5 of 9 PHQ symptoms, including anhedonia or depressed mood, more than half the days in the past 2 weeks.</p>¶<p>Diagnostic data were also reported for the 2-item yes/no PHQ≥1 alone and the PHQ-9≥10 alone, which were already reported for this cohort in McManus, 2005 <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0052654#pone.0052654-McManus1" target="_blank">[22]</a>, and for the PHQ-2≥2, which was already reported for this cohort in Thombs, 2008 <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0052654#pone.0052654-Thombs4" target="_blank">[11]</a>.</p>#<p>The cutoffs of ≥3 and ≥4 on the BDI-II cognitive subscale were both identified as optimal in the published manuscript. The diagnostic data for the BDI-II cognitive subscale ≥4 are sensitivity 82% (95% CI: 59% to 94%), specificity 89% (95% CI: 81% to 93%), positive predictive value 52% (95% CI: 34% to 69%), and negative predictive value 97% (95% CI: 92% to 99%).</p>**<p>Diagnostic data were reported for the literature-based cutoffs of BDI≥14 and GDS≥11 in the previous systematic review <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0052654#pone.0052654-Thombs2" target="_blank">[5]</a>. However, the cutoffs of BDI≥10 and GDS≥13 were identified as optimal by the study authors.</p>††<p>The diagnostic data were provided by the authors of the original studies to correct inconsistencies in the published manuscripts.</p>‡‡<p>Demographic data based on full study sample of 747 patients, rather than the 218 patients included in the analyses reported in the table. ACS = acute coronary syndrome; AHA = American Heart Association; AMI = acute myocardial infarction; BDI = Beck Depression Inventory; BDI-II = Beck Depression Inventory - II; CABG = coronary artery bypass graft surgery; CAMDEX = Cambridge Examination for Mental Disorders of the Elderly; CES-D = Center for Epidemiological Studies Depression Scale; CES-D-10 = 10-item version of the Center for Epidemiological Studies Depression Scale; CHD = coronary heart disease; CHF = congestive heart failure; CI = confidence interval; DIS = Diagnostic Interview Schedule; GDS = Geriatric Depression Scale; HADS = Hospital Anxiety and Depression Scale, total score; HADS-A = Anxiety Subscale of the Hospital Anxiety and Depression Scale HADS-D = Depression Subscale of the Hospital Anxiety and Depression Scale; ICD = implantable cardioverter defibrillator; IHD = ischemic heart disease; MINI = Mini International Neuropsychiatric Interview; MINI-Plus = extended version of Mini International Neuropsychiatric Interview; PHQ-2 = Patient Health Questionnaire - 2; PHQ-9 = Patient Health Questionnaire - 9; PTCA = percutaneous transluminal coronary angioplasty; SCAN = Schedule for Assessment of Neuropsychiatric Disorders; SCID-IV = Structured Clinical Interview for DSM-IV.</p

Outcomes for Randomized Controlled Trials of Depression Treatment.

*<p>All reported depression outcomes were assessed at the end of the treatment period except MIND-IT <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0052654#pone.0052654-vanMelle1" target="_blank">[33]</a> where depression outcomes were assessed 18 months post-myocardial infarction (0–9 months after completion of treatment).</p>†<p>Cardiovascular serious adverse events = myocardial infarction, congestive heart failure, worsening angina, stroke, or other cardiovascular events.</p>‡<p>Of the 2,481 randomized patients in the ENRICHD trial who met eligibility criteria for MDD, minor depression, or dysthymia and/or low social support <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0052654#pone.0052654-Berkman1" target="_blank">[31]</a>, data are reported only for the subset of 955 randomized patients diagnosed with MDD. Original data for the ENRICHD trial were obtained from the National Heart Lung and Blood Institute.</p>§<p>In the depression outcome analyses presented, the last-observation-carried-forward approach was applied for missing data. The original published report of the ENRICHD trial <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0052654#pone.0052654-Berkman1" target="_blank">[31]</a> reported outcome data for completers. Based on completer data only, Δ HAMD-17: Hedges' <i>g</i> = 0.24, 95% CI 0.09 to 0.39 (N = 690, CBT: 348, UC: 342). Δ BDI: Hedges' <i>g</i> = 0.36, 95% CI 0.21 to 0.51 (N = 699, CBT: 357, UC: 342).</p>∥<p>The Honig, 2007 <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0052654#pone.0052654-Honig1" target="_blank">[32]</a> study was an RCT nested within the MIND-IT study <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0052654#pone.0052654-vanMelle1" target="_blank">[33]</a>.</p>¶<p>Total cardiac events include cardiac death, recurrent myocardial infarction, revascularization, heart failure, myocardial ischemia, and ventricular arrhythmia. 17 patients were lost to follow-up (Tx, n = 196; UC, n = 118).</p>#<p>Patients were assessed with HAMD-17 at 16 weeks, but not 24 weeks.</p>**<p>Major adverse cardiac events = events involving death or requiring hospitalization.</p>††<p>Hazard ratio from Kaplan-Meier analysis, but number of deaths per group not provided for follow-up study (Glassman AH, Bigger JT,Jr, Gaffney M. Psychiatric characteristics associated with long-term mortality among 361 patients having an acute coronary syndrome and major depression: Seven-year follow-up of SADHART participants. Arch Gen Psychiatry. 2009 Sep;66:1022–9). BDI = Beck Depression Inventory; BDI-II = Beck Depression Inventory – II; CBT = cognitive behavior therapy; CM = clinical management; CGI-I = Clinical Global Impression-Improvement; CGI-S = Clinical Global Impression-Severity; CI = confidence interval; CREATE = Canadian Cardiac Randomized Evaluation of Antidepressant and Psychotherapy Efficacy trial; ENRICHD = Enhancing Recovery in Coronary Heart Disease Patients; HAMD-17 = 17-item Hamilton Depression Rating Scale; HAMD-24 = 24-item Hamilton Depression Rating Scale; HAMD-31 = 31-item Hamilton Depression Rating Scale; IPT = interpersonal therapy; MADRS = Montgomery-Asberg Depression Rating Scale; MI = myocardial infarction; MIND-IT = Myocardial Infarction and Depression-Intervention trial; NA = not applicable; SADHART = Sertraline Antidepressant Heart Attack Randomized trial; SADHART-CHF = Sertraline Against Depression and Heart Disease in Chronic Heart Failure; SCL-90-D = depression subscale of the Symptom Checklist 90; Tx = treatment; UC = usual care.</p

Characteristics of Randomized Controlled Trials of Depression Treatment.

*<p>The International Committee of Medical Journal Editors (ICMJE) clinical trial registration policy requires prospective registration (i.e., prior to patient enrollment) of trials that began on or after July 1, 2005, and also requires registration of trials that were ongoing as of July 1, 2005 (i.e., registration after the beginning of patient enrollment).</p>†<p>Factorial design with patients randomized to citalopram or placebo and IPT or CM.</p>‡<p>Of the 2,481 randomized patients in the ENRICHD trial who met eligibility criteria for MDD, minor depression, or dysthymia and/or low social support <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0052654#pone.0052654-Berkman1" target="_blank">[31]</a>, data are reported only for the subset of 955 randomized patients diagnosed with MDD at trial entry. Original data for the ENRICHD trial were obtained from the National Heart Lung and Blood Institute.</p>§<p>Maximum duration of the CBT intervention was 6 months. Group therapy could extend 12 additional weeks and adjunctive sertraline treatment for up to 12 months.</p>∥<p>The Honig, 2007 <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0052654#pone.0052654-Honig1" target="_blank">[32]</a> study was an RCT nested within the MIND-IT study <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0052654#pone.0052654-vanMelle1" target="_blank">[33]</a>.</p>¶<p>Outcome at 8 weeks were reviewed instead of 24-week results because 8 weeks open treatment with citalopram was offered in the case of refusal or insufficient treatment response <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0052654#pone.0052654-vanMelle1" target="_blank">[33]</a>.</p>#<p>Author-industry financial ties were not reported. The authors of the MIND-IT trial <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0052654#pone.0052654-vanMelle1" target="_blank">[33]</a>, of which the Honig, 2007 study <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0052654#pone.0052654-Honig1" target="_blank">[32]</a> was a nested RCT, declared no conflicts of interest. However, of the 12 authors of the Honig, 2007 study <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0052654#pone.0052654-Honig1" target="_blank">[32]</a> only 9 were authors of the published MIND-IT report <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0052654#pone.0052654-vanMelle1" target="_blank">[33]</a>.</p>**<p>Long-term cardiovascular outcomes from Glassman AH, Bigger JT,Jr, Gaffney M. Psychiatric characteristics associated with long-term mortality among 361 patients having an acute coronary syndrome and major depression: Seven-year follow-up of SADHART participants. Arch Gen Psychiatry. 2009 Sep;66:1022–9. ACS = acute coronary syndrome; AMI = acute myocardial infarction; CBT = cognitive behavior therapy; CHD = coronary heart disease; CM = clinical management; CREATE = Canadian Cardiac Randomized Evaluation of Antidepressant and Psychotherapy Efficacy trial; ENRICHD = Enhancing Recovery in Coronary Heart Disease Patients; HF = heart failure; IPT = interpersonal therapy; MIND-IT = Myocardial Infarction and Depression-Intervention trial; NA = not applicable; NR = not reported; SADHART = Sertraline Antidepressant Heart Attack Randomized trial; SADHART-CHF = Sertraline Against Depression and Heart Disease in Chronic Heart Failure; Tx = treatment; UC = usual care.</p