David V. Sheehan

The validity of the Mini International Neuropsychiatric Interview (MINI) according to the SCID-P and its reliability

Summary The Mini International Neuropsychiatric Interview (MINI) is a short diagnostic structured interview, developed in clinician (MINI-CR) and patient-rated (MINI-PR) formats, for 17 Diagnostic and Statistical Manual (DSM)-III-R Axis I psychiatric disorders. This study, which investigates the validity of the MINI in relation to the Structured Clinical Interview for DSM-III-R Patients (SCID-P), was conducted in conjunction with a similar study, investigating the validity of the MINI in relation to the Composite International Diagnostic Interview (CIDI) for International Statistical Classification of Disease (ICD)-10. Both studies also examined the inter-rater and test-retest reliability of the MINI. Three hundred and seventy subjects (330 in Florida and 40 in Paris) participated in the validation of the MINI versus the SCID-P. Of these, 308 had at least one psychiatric disorder and 62 were non-patient adult controls. Eighty of the subjects (40 in Florida and 40 in Paris) also participated in the parallel study of the validity of the MINI versus the CIDI. The 330 Florida subjects first completed the patient-rated version of the MINI. All subjects were administered the MINI-CR (after the MINI-PR in the case of the Florida subjects), followed by the SCID-P. The MINI-CR was rated by two interviewers for 42 subjects in Florida and 42 in Paris (inter-rater reliability test) and readministered by a third blind interviewer one to two days after the initial rating (test-retest reliability test). Overall, the results supported the validity and reliability of the MINI. In addition, administration of the MINI-CR took half as long as administration of corresponding sections of the SCID-P. The application of short structured interviews in clinical and research settings is discussed.

The measurement of disability.

The frequent occurrence of desynchrony between psychiatric symptoms and disability makes it necessary to measure disability/ functional impairment in addition to psychiatric symptoms when tracking treatment outcome. Existing disability measures in psychiatry are comprehensive but lengthy. There is a need for short, simple, cost-effective, sensitive measures of disability and functional impairment in psychiatric disorders. We developed a discretized analog disability scale (DISS) which uses visual-spatial, numeric and verbal descriptive anchors to assess disability across three domains: work, social life and family life. The DISS has proved to be very sensitive to change in drug treatment studies in psychiatry. The usefulness of the DISS in assessing disability in terms of work, social and family relationships is discussed.

Assessing psychiatric impairment in primary care with the Sheehan Disability Scale

Objective: Several recent studies have documented that substantial functional impairment is associated with many of the mental disorders seen in primary care. However, brief measures of mental health-related functional impairment are not commonly applied in primary care settings. The Sheehan Disability Scale (SDS), a three-item instrument for assessing such impairment, is evaluated in this study. Method: A psychometric analysis of the SDS was conducted with a sample of 1001 primary care patients at Kaiser Permanente in Oakland, California. The SDS and the Symptom Driven Diagnostic System for Primary Care assessments were completed. Results: The internal consistency reliability of the SDS is high, with coefficient alpha of 0.89. The construct validity was substantiated in two ways. A one-factor model fit the data quite well. Furthermore, patients with each of six psychiatric disorders had significantly higher impairment scores than those who did not. Finally, over 80 percent of the patients with mental disorder diagnoses had an elevated SDS score and nearly 50 percent of those with elevated SDS scores had at least one disorder. Conclusions: The psychometric properties of the SDS were evaluated in primary care. The internal consistency reliability was high. The analyses also lend empirical support for the construct validity. The scale is a sensitive tool for identifying primary care patients with mental health-related functional impairment, who would warrant a diagnostically-oriented mental health assessment.

Reliability and validity of the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).

OBJECTIVE To investigate the concurrent validity and reliability of the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID), a short structured diagnostic interview for DSM-IV and ICD-10 psychiatric disorders in children and adolescents. METHOD Participants were 226 children and adolescents (190 outpatients and 36 controls) aged 6 to 17 years. To assess the concurrent validity of the MINI-KID, participants were administered the MINI-KID and the Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime Version (K-SADS-PL) by blinded interviewers in a counterbalanced order on the same day. Participants also completed a self-rated measure of disability. In addition, interrater (n = 57) and test-retest (n = 83) reliability data (retest interval, 1-5 days) were collected, and agreement between the parent version of the MINI-KID and the standard MINI-KID (n = 140) was assessed. Data were collected between March 2004 and January 2008. RESULTS Substantial to excellent MINI-KID to K-SADS-PL concordance was found for syndromal diagnoses of any mood disorder, any anxiety disorder, any substance use disorder, any ADHD or behavioral disorder, and any eating disorder (area under curve [AUC] = 0.81-0.96, kappa = 0.56-0.87). Results were more variable for psychotic disorder (AUC = 0.94, kappa = 0.41). Sensitivity was substantial (0.61-1.00) for 15/20 individual DSM-IV disorders. Specificity was excellent (0.81-1.00) for 18 disorders and substantial (> 0.73) for the remaining 2. The MINI-KID identified a median of 3 disorders per subject compared to 2 on the K-SADS-PL and took two-thirds less time to administer (34 vs 103 minutes). Interrater and test-retest kappas were substantial to almost perfect (0.64-1.00) for all individual MINI-KID disorders except dysthymia. Concordance of the parent version (MINI-KID-P) with the standard MINI-KID was good. CONCLUSIONS The MINI-KID generates reliable and valid psychiatric diagnoses for children and adolescents and does so in a third of the time as the K-SADS-PL.

Nicotinic acetylcholine receptors as targets for antidepressants

While the monoamine deficiency hypothesis of depression is still most commonly used to explain the actions of antidepressant drugs, a growing body of evidence has accumulated that is not adequately explained by the hypothesis. This article draws attention to contributions from another apparently common pharmacological property of antidepressant medications—the inhibition of nicotinic acetylcholine receptors (nAChR). Evidence is presented suggesting the hypercholinergic neurotransmission, which is associated with depressed mood states, may be mediated through excessive neuronal nicotinic receptor activation and that the therapeutic actions of many antidepressants may be, in part, mediated through inhibition of these receptors. In support of this hypothesis, preliminary evidence is presented suggesting that the potent, centrally acting nAChR antagonist, mecamylamine, which is devoid of monoamine reuptake inhibition, may reduce symptoms of depression and mood instability in patients with comorbid depression and bipolar disorder. If this hypothesis is supported by further preclinical and clinical research, nicotinic acetylcholine receptor antagonists may represent a novel class of therapeutic agents for treating mood disorders.

DSM-IH-R Psychotic Disorders: procedural validity of the Mini International Neuropsychiatric Interview (MINI). Concordance and causes for discordance with the CIDI.

OBJECTIVES the Mini International Neuropsychiatric Interview (MINI) is a short diagnostic structured interview (DSI) designed to generate positive diagnosis for the main Diagnostic and Statistical Manual (DSM)-III-R/IV Axis I disorders and to explore the symptoms of Criterion A for Schizophrenia (Sc) to rule out the presence of Psychotic Disorders. The procedural validity of the MINI was investigated in psychiatric patients using the Composite International Diagnostic Interview (CIDI) as a gold standard in Europe and the Structured Clinical Interview for DSM-III-R (SCID-P)in the US. This paper presents the concordance and the reasons for discordance between the MINI and the CIDI for DSM-III-R Psychotic and Mood Disorders. No study had systematically analysed the sources of disagreement between DSI based on the same operational criteria in psychotic patients. METHODS 256 consecutively recruited psychiatric patients and 50 non-psychiatric subjects passed the MINI and the CIDI. RESULTS concordance was good for the presence of Major Depressive Episode (MDE), Manic Episode, Psychotic Disorders, syndromes or symptoms (0.65 to 0.82). Inconsistencies in evaluation of the disorder recency accounted for 25 to 40% of discordance for current diagnoses. Fifty-three percent of discordance for lifetime Manic Episode resulted from inconsistencies in the severity of the index episode. Fifty percent of discordance for the diagnosis of Psychotic Disorders was due to algorithmic differences between the two DSI. CONCLUSION the MINI yields reliable DSM-III-R diagnoses within a short time frame (22 minutes). Depending on the quantitative and the qualitative analyses of discrepancies between the MINI and the CIDI for Psychotic Disorders and Mood Episodes, we proposed and tested modifications leading to improvements in both interviews. The procedural validity of the modified MINI according to the modified CIDI was found to be very good.

Assessing treatment effects in clinical trials with the discan metric of the Sheehan Disability Scale.

The Sheehan Disability Scale (SDS) is a patient-rated, discretized analog measure of functional disability in work, social, and family life. Its increasing use in clinical trials in psychiatry suggests a need to assess its responsiveness and interpretability. In this paper we identify and review studies in which the SDS was used as a treatment outcome measure. Our objectives are (i) to evaluate the sensitivity of the SDS to treatment effects and (ii) to examine potential thresholds or cutoff scores for remission and response. Studies for the review were retrieved from the National Library of Medicines PubMed database (1966 to 21 March 2007) and other sources. All studies had to use the SDS, be double-blind, controlled or large open-label trials in English. Studies assessing nonpharmacological treatments, long-term trials (>12 weeks), small n trials (less than 20 patients per treatment arm) and trials for conditions other than one of the anxiety disorders, depression, or premenstrual dysphoric disorder were excluded. Extracted data included the diagnostic target of treatment, n, study design, and method of analysis. Initial, endpoint and/or mean change scores were extracted from tables, text, or extrapolated from figures. In all, 37 studies meeting the inclusion criteria were retrieved and reviewed. All of the studies treated the SDS as a numeric scale and analyzed mean change or endpoint differences with parametric statistics. Three provided additional outcome data using nonparametric response or remission criteria. Overall, the SDS performed well in discriminating between active and inactive treatments. The results indicate that the SDS is sensitive to treatment effects. To establish reliable and valid cutoff scores for remission and response, there is a need to supplement parametric analyses using mean change and endpoint differences with nonparametric analyses showing the percentage meeting specified response and remission criteria. In addition, the percentages with endpoint scores of zero should be reported.

The relative efficacy of high‐dose buspirone and alprazolam in the treatment of panic disorder: a double‐blind placebo‐controlled study

This 8‐week double‐blind placebo‐controlled trial investigated the relative efficacy and safety of alprazolam and buspirone in the treatment of panic disorder. Alprazolam (mean ± SD dose 5.2 ± 2.6 mg) produced a rapid and sustained improvement in panic attacks, anxiety, phobias, and disability and was superior to buspirone (mean ± SD dose 61 ± 26.5 mg) and placebo on all of these measures on completer (n= 85) and endpoint analysis (n= 92). Although higher doses of buspirone were used in this study than in previous trials, buspirone was not superior to placebo on any of the outcome measures. The results were disappointing in light of buspirones benign side effect profile and low abuse potential.

Is buspirone effective for panic disorder

Buspirone was compared with imipramine and placebo in the treatment of panic disorder in an 8-week, double-blind controlled study of 52 randomly assigned patients. The side effect profile of buspirone was less disruptive than that of imipramine. Buspirone was not significantly superior to placebo in its antipanic or anxiolytic effects in panic disorder patients.

Comparing the effects of antidepressants: Consensus guidelines for evaluating quantitative reviews of antidepressant efficacy

With increasing numbers of treatment options available for patients with major depression over the last decade and the growing body of evidence describing their efficacy and safety, clinicians often find it difficult to determine the best and most appropriate evidence-based treatment for each patient. Systematic reviews utilizing statistical methods that synthesize and evaluate data from a number of studies have become increasingly more available over the past decade. We review major findings and lessons learned from salient examples of quantitative analyses of antidepressant research and provide recommendations for meta-analysts, journal and grant reviewers, and research ‘consumers’ (ie, clinicians) for conducting, reporting, and evaluating such analyses.