by Joan Busner, PhD; Stuart L. Kaplan, MD; Nicholas Greco, IV, MS; and David V. Sheehan, MD, MBA
Dr. Busner is Clinical Associate Professor of Psychiatry, Penn State College of Medicine, and Practice Leader, United Biosource Corporation, Wayne, Pennsylvania; Dr. Kaplan is Clinical Professor of Psychiatry, Penn State College of Medicine, Hershey, Pennsylvania; Mr. Greco is an employee of Abbott Laboratories, Abbott Park, Illinois, and the Adler School of Professional Psychology, Chicago, Illinois; Dr. Sheehan is Distinguished University Health Professor, Professor of Psychiatry, and Director, Depression and Anxiety Disorders Research Institute, University of South Florida College of Medicine, Tampa, Florida.

Innov Clin Neurosci. 2011;8(4):19–23

Funding: There was no funding for this article.

Financial disclosures: Dr. Busner is an employee of United BioSource Corporation; Dr. Kaplan does not have any conflicts of interest relevant to the content of this article; Mr. Greco is an employee of Abbott Laboratories; and Dr. Sheehan has received grant funding support, or been affiliated or received honoraria and travel expenses related to lectures/presentations or consultant activities from the following organizations: Abbott Laboratories, Ad Hoc Committee, Treatment Drug & Assessment Research Review, Alexa, Alza Pharmaceuticals, American Medical Association, American Psychiatric Association Task Force on Benzodiazepine Dependency, American Psychiatric Association Task Force on Treatments of Psychiatric Disorders, American Psychiatric Association Working Group to revise DSM III Anxiety Disorders Section, Anclote Foundation, Anxiety Disorders Resource Center, Anxiety Drug Efficacy Case, U.S. Food & Drug Administration, Applied Health Outcomes/ XCENDA, AstraZeneca, Avera Pharmaceuticals, Boehringer Ingelheim, Boots Pharmaceuticals, Bristol-Myers Squibb, Burroughs Wellcome, Cephalon, Charter Hospitals, Ciba Geigy, Committee (RRC) of N.I.M.H. on Anxiety and Phobic Disorder Projects, Connecticut & Ohio Academies of Family Physicians, Cortex Pharmaceutical, Council on Anxiety Disorders, CPC Coliseum Medical Center, Cypress Bioscience, Dista Products Co, Division of Drugs & Technology, American Medical Association, EISA, Eli Lilly, Excerpta Medica Asia, Faxmed, Inc, Forest Laboratories, Glaxo Pharmaceuticals, GlaxoSmithKline, Glaxo-Wellcome, Hospital Corporation of America, Humana, ICI, INC Research, International Clinical Research (ICR), International Society for CNS Drug Development (ISCDD), Janssen Pharmaceutica, Jazz Pharmaceuticals, Kali-Duphar, Labopharm, Layton Bioscience, Lilly Research Laboratories, Lundbeck, Denmark, Marion Merrill Dow, McNeil Pharmaceuticals, Mead Johnson, Medical Outcome Systems, MediciNova, Merck Sharp & Dohme, National Anxiety Awareness Program, National Anxiety Foundation, National Depressive & Manic Depressive Association, National Institute of Drug Abuse, National Institute of Health (NIH), Novartis Pharmaceuticals Corp., Novo Nordisk, Organon, Orion Pharma, Parexel International Corporation, Parke-Davis, Pfizer, Pharmacia, Pharmacia & Upjohn, Philadelphia College of Pharmacy & Science, Pierre Fabre, France, Quintiles, Rhone Laboratories, Rhone-Poulenc Rorer Pharmaceuticals, Roche, Roerig, Sandoz Pharmaceuticals, Sanofi-Aventis, Sanofi-Synthelabo Recherche, Schering Corporation, Sepracor, Shire Laboratories, Inc., SmithKlineBeecham, Solvay Pharmaceuticals, Takeda Pharmaceuticals, Tampa General Hosp. University of South Florida Psychiatry Center, University of South Florida College of Medicine, TAP Pharmaceuticals, Targacept, TGH-University Psychiatry Center, Tikvah Therapeutics, Titan Pharmaceuticals, United Bioscience, The Upjohn Co., U.S. Congress-House of Representatives Committee, USF Friends of Research in Psychiatry, Board of Trustees, Warner Chilcott, World Health Organization, Worldwide Clinical Trials, Wyeth-Ayerst, ZARS, Zeneca Pharmaceuticals, Neuronetics

Key words: clinical assessment, research tools, research measures; psychopathology assessment

Abstract: Many psychopathology research assessment tools can be used easily and productively in clinical practice. We conducted a workshop in 2009 and 2010 at the American Psychiatric Association annual meeting designed to bring clinicians some commonly used adult research measures with broad applicability to a variety of conditions. This article reviews what was most helpful to the practicing clinicians at the workshop.

Introduction

Although there are many benefits to incorporating research measures into clinical practice, we have been repeatedly struck by the reluctance of many clinicians to do so. Some clinicians believe the measures will be too time-consuming. Some see the measures as too prescribed or “mechanical.” Some believe the measures are too complex or difficult to use with facility, and others worry that the measures will impair the clinical relationship or reduce the role of the clinician to one of a cold or unfeeling automaton unable to veer from cookbook-like algorithms. Many clinicians, perhaps most, are simply unaware of the potential benefits of using such instruments.

Among the benefits of using research measures in clinical settings are their systematic coverage of diagnoses and symptoms, their documentation of the patient’s clinical state, their ability to track outcome and measure the effectiveness of interventions, and their ability to foster mutuality between the patient and the clinician in working toward the common goal of clinical improvement.

Research measures can be broadly divided into those that provide tools for establishing diagnoses and those that measure symptoms of specific illnesses.

Diagnostic Interviews

Diagnostic interviews systematically cover the more common Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) diagnoses, allowing the clinician to rule the diagnoses in or out. These measures are invaluable at intake or when new issues with potential diagnostic significance arise. Typically, diagnostic interviews include screening items that allow the clinician to “skip” to other sections if the criteria for a diagnosis are not immediately met. In this way, the clinician may move with relative ease from nonproductive areas to those more suited to the particular patient. In a short period of time, the clinician is able to identify those diagnostic areas of most relevance, ensure that important areas have not been overlooked, and provide documentation of each symptom assessed.

There is an art to good diagnosis, and the clinical acumen of a brilliant diagnostician is irreplaceable. Nonetheless, without a structured instrument, the systematic coverage of every symptom for every major diagnosis is difficult to accomplish, even for the most skilled practitioner, and diagnoses or other areas of treatment focus are sometimes missed.

Mini-International Neuropsychiatric Interview. An example of an instrument that provides a comprehensive assessment of DSM-IV diagnoses briefly and easily is the Mini-International Neuropsychiatric Interview (MINI.).[1] The MINI is a structured psychiatric interview that provides scripted prompts that lead to yes/no answers. The clinician is encouraged to probe when needed to ensure that the patient has correctly understood the intent of the question and to ensure that the response truly meets the DSM-IV symptom being sought. Algorithms throughout the instrument lead to DSM-IV diagnoses. The MINI is available for a nominal charge to clinicians in practice and can be downloaded at www.medical-outcomes.com. The MINI can be administered either by the clinician via pen and pencil or computer or by patients themselves via computer. In the clinician-administered version, the clinician asks the questions and determines, ultimately, whether each symptom should be coded yes or no. In a short amount of time (15 minutes on average), the MINI covers a thorough inventory of most of the common DSM-IV diagnoses and provides the clinician with precise documentation on the diagnoses likely to be present and absent. Such structured interviews are valuable in guiding treatment while also providing clear-cut clinic chart and insurance documentation. A less obvious benefit benefit of using the MINI at intake is the therapeutic alliance it can create with the patient.

In our experience, patients view the administration of a structured diagnostic instrument as a sign of clinician expertise and beneficence; patients are frequently grateful that someone is finally asking relevant, precisely targeted questions. When administered carefully and thoughtfully, patients welcome the specific clarification of a previously ill-defined or frightening illness. We have found that patients appreciate the thorough and comprehensive approach inherent in the interview. In contrast to the clinician’s fear that patients will balk at or feel barraged by stilted, repetitive questions, our experience suggests that patients like the instrument and its systematic, symptom-based approach. The structured psychiatric interview does not replace the clinical interview; rather it enhances it.

Diagnostic interviews can be retained in the patient’s chart, with notes supporting or refuting diagnoses of interest, clearly retrievable for clinical reference, administrative, or insurance purposes.

Symptom Inventories

After a structured or clinical diagnostic interview establishes that a patient’s symptoms meet criteria for a DSM-IV diagnosis, symptom inventories are useful in assessing the severity of the illness. Symptom inventories are useful in further substantiating and illuminating additional features of the diagnosed illness.

There are many good research symptom inventories that transfer quite easily from the research setting to the clinic. To some extent, the choice of scale is dictated by the patient population in a particular practice. Two recent useful references for symptom inventories are the Handbook of Psychiatric Measures[2] and the Handbook of Clinical Rating Scales and Assessment in Psychiatry and Mental Health.[3] An internet search for a specific disease can also be productive in locating disease-specific instruments. Note that some measures must be purchased or can only be used with permission. Typically, symptom inventories are divided into those that are clinician-administered and those that are patient self-reported.

Symptoms inventories: clinician-administered. For brevity and illustrative purposes, we have highlighted two common clinician-administered symptom inventories that are easily incorporated into clinical practice. The measures discussed are available free of charge by their authors and cover symptoms frequently encountered in a general practice. The measures are almost ubiquitous in psychopharmacology trials for depression and anxiety, respectively.

Structured Interview Guide for the Montgomery Asberg Rating Scale. The Structured Interview Guide for the Montgomery Asberg Rating Scale (SIGMA)[4] is a well-known structured adaptation of the Montgomery Asberg Depression Rating Scale (MADRS), a widely used depression measure in United States Food and Drug Administration (FDA)-regulated pharmacology trials.[5] For clinicians not specifically trained in the use of the MADRS, we recommend the SIGMA as it contains scripted prompts that make administration somewhat easier. The SIGMA retains all 10 of the MADRS items. Each item is rated on a scale of 0 to 6 with increasing severity; total scores are computed by simply tallying the individual item ratings and range from 0 to 60. Scores above 20 are usual in patients with major depressive disorder (MDD), and scores below 10 are generally seen as falling within the normal range. The instrument is not a diagnostic assessment and the symptoms are not directly those of DSM-IV, rather the items were selected empirically on the basis of their ability to detect antidepressant drug effects. In clinical practice, the instrument can easily be used to assess depressive symptom severity and track antidepressant response. The SIGMA takes approximately 20 minutes to administer.

Structured Interview Guide for the Hamilton Anxiety Scale. The Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A) is a structured version of the Hamilton Anxiety Rating Scale. It was developed by Janet Williams6 and is available at no cost from Dr. Williams directly ([email protected]). The Hamilton Anxiety Scale (HAM-A)[7] is a gold-standard measure for anxiety disorder studies and has been included in anxiety research studies for decades. The SIGH-A retains the 14 items of the HAM-A but contains scripted prompts to guide the interviewer through all of the content covered by the items. The SIGH-A can be completed in approximately 20 minutes. Each item is scored on a scale of 0 (not present) to 4 (severe). Total scores are derived by adding individual item scores and range from 0 to 54. The instrument is applicable to measuring anxiety in disorders where anxiety predominates (e.g., generalized anxiety disorder). Like the HAM-A, the SIGH-A does not make a specific anxiety diagnosis, but it does provide a good assessment of the severity of the anxiety in each disorder. In research studies, a total score of approximately 20 is typically associated with a “moderate” level of anxiety and a total score of less than 10 is usually considered to fall within the normal range.[8]

Symptoms inventories: patient self-reported. Patient self-reported scales have particular appeal to the busy practitioner in that they require less clinician time. We highlight three commonly used patient self-report scales, available at no cost, that are quite useful in general practice. This list is by no means exhaustive. We encourage clinicians to investigate other resources to locate measures that are specific to their particular clinical needs.

Quick Inventory for Depression Ratings, Self-Report (QIDS-SR). The Quick Inventory for Depression Ratings, Self-Report (QIDS-SR)[9] is a 16-item self-report scale that was used in the National Institutes of Mental Health (NIMH) Sequenced Treatment Alternatives to Relieve Depression (STAR-D) trial. It is completed by the patient and scored afterward by the clinician; a scoring instructions sheet is included with the instrument. The scale and instructions are available at no cost from the IDS/QIDS website, www.ids-qids.org. The QIDS-SR covers nine symptom groups, including mood, sleep disturbance, appetite disturbance, and suicidal ideation. The scoring instruction sheet must be used to calculate the total score but this is easily accomplished in a short time. Total scores range from 0 to 27. In general, total scores above 10 can be viewed as correlating with “moderate” depression, according to the QIDS-SR authors. The scale has been shown to correlate with clinician-rated depression symptom measures. As with other depression symptom inventories, the QIDS-SR does not make a diagnosis of MDD. The instrument can be used as an adjunct to a clinical interview; it can be completed by the patient prior to the visit or in the waiting room. Scores can be used to assist in establishing initial symptoms of potential concern, assess depression severity, and track treatment response.

Adult ADHD Self-Report Scale version.1.1. The Adult ADHD Self-Report Scale version.1.1 (ASRS v1.1) is an 18-item self-report scale developed by the World Health Organization (WHO) in conjunction with a team of ADHD (attention deficit hyperactivity disorder) experts.[10] The 18 items are essentially the nine DSM-IV inattention and the nine DSM-IV hyperactivity/impulsive ADHD symptoms, with slight rewording so as to make them more applicable to adults as opposed to children about whom the DSM-IV diagnostic criteria originally applied. Patients endorse the frequency of each symptom’s occurrence on a scale of 0 to 4 where 0=never and 4=very often. Given the similarity of the items to the DSM-IV symptoms, the instrument is helpful to use with a clinical interview in establishing diagnosis. The instrument does not in and of itself provide all of the necessary elements for an ADHD diagnosis, but we believe it provides a helpful springboard from which the clinician can begin to discuss each current symptom endorsed. For diagnostic purposes, a clinical interview must establish impairment, illness course, presence of illness in childhood, absence of known other etiological causes, and other relevant DSM-IV criteria. No total score guidelines are provided; rather, the instrument is used to gather information and track outcomes over time.

A shorter six-item ASRS “screener” exists that can be used in the initial assessment period to help determine the likelihood a patient will have ADHD.[11,12] Endorsement of four or more symptoms at the requisite level (i.e., “sometimes” for three of the symptoms and “very often” for three other of the symptoms) has been recommended as a cutoff for then pursuing a more thorough clinical interview with the patient to determine if the full DSM-IV criteria for the diagnosis are present.

Post-Traumatic Stress Disorder Checklist-Civilian Version. The Post-Traumatic Stress Disorder Checklist-Civilian Version (PCL-C)[13] is the “civilian” version of a PTSD scale currently used by the United States military services to assess combat-related trauma. The civilian version is available free of charge at the United States Department of Veterans Affairs National Center for PTSD website, www.ptsd.va.gov/professional/pages/assessments, along with scoring instructions, instructions as to its potential assistance in formulating a PTSD diagnosis, and guidelines for assessing the significance of total score ranges. The civilian version removes combat-specific items found in the military version (PCL-M) and has been used to assess PTSD symptoms in varied groups, such as patients with breast cancer[14] and individuals with other nonmilitary trauma.[15] The PCL-C consists of 17 items, each rated on a 1 to 5 severity scale relative to the past month. Total scores are derived by adding the item responses and range from 17 to 85. The Veterans Affairs website, www.ptsd.va.gov/
professional/pages/assessments, provides suggested score ranges for gauging severity for different patient populations.

Additional Considerations

In research studies, treatment efficacy is usually gauged by reductions in total scores on symptom measures. The clinician, however, may choose to target only certain symptoms of clinical relevance, such as the phobic avoidance item on the SIGH-A. Symptom scales provide clinicians the ability to systemically follow specific symptoms.

A Caution About Total Scores

Total scores are often a useful “at a glance” measure by which to gauge illness severity and track treatment outcome. Even in research studies, however, the investigator caring for the patient must inspect individual items endorsed because fluctuations in individual items may indicate clinical worsening that the total score alone would obscure. For example, from one visit to the next, a patient with depression whose sleep and eating improved modestly, but whose suicidality increased dramatically, would not necessarily show a total score change.

Discussion

Many of the qualities that make tools valuable for research also apply to good clinical care. Research tools must accurately yield diagnoses and detect treatment-related symptom changes. The needs of conscientious clinicians are much the same.

Clinicians are often pleased to learn the utility and applicability of a variety of research measures to their practices. Although clinicians may use research instruments in their clinic patients, in research studies the measures require further training in standardized administration and other aspects of their use. Further, clinicians should be aware that there is a large amount of data about validity and reliability on these scales that are not included in this article but may be obtained in the published literature or through the scale authors. Rigorous assessment of reliability and validity of the use of the instruments in clinical care may not have been established.

Clinicians routinely rely on journal articles and package inserts to guide their pharmacologic interventions; these articles and package inserts are almost universally linked to symptom inventory results and structured, interview-generated diagnoses. The clinician who is familiar with these instruments is at an advantage with respect to understanding the literature and understanding the reported effects of medications in their own patients.
Psychiatric residents and other clinical trainees gain immeasurably by becoming familiar with research measures and the systematic symptom and diagnostic assessment they afford.

From a medicolegal perspective, research measures help document the clinician’s careful investigation of the patient’s psychiatric illness and monitoring of treatment response over time.

We encourage interested clinicians to investigate the benefits of these measures in clinical settings.

References
1. Sheehan DV, Lecrubier Y, Sheehan KH, et al. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 (Suppl 20):22–33;quiz 34–57.
2. Rush AJ, First MB, Blacker D, American Psychiatric Association Task Force for the Handbook of Psychiatric Measures. Handbook of Psychiatric Measures. 2nd ed. Washington, DC: American Psychiatric Pub.; 2008.
3. Baer L, Blais MA. Handbook of Clinical Rating Scales and Assessment in Psychiatry and Mental Health. New York: Humana Press; 2010.
4. Williams JB, Kobak KA. Development and reliability of a structured interview guide for the Montgomery Asberg Depression Rating Scale (SIGMA). Br J Psychiatry. 2008;192(1):52–58.
5. Montgomery SA. Measures of Depression. London: Fulcrum Press: 1978.
6. Williams JBW. Structured interview guide for the Hamilton Anxiety Scale (SIGH-A). Biometrics Research Department, New York State Psychiatric Institute, New York, New York; Revision 15 Jan 2008.
7. Hamilton M. The assessment of anxiety states by rating. Br J Med Psychol. 1959;32(1):50–55.
8. Matza LS, Morlock R, Sexton C, et al. Identifying HAM-A cutoffs for mild, moderate, and severe generalized anxiety disorder. Int J Methods Psychiatr Res. 2010;19(4):223–232.
9. Rush AJ, Trivedi MH, Ibrahim HM, et al. The 16-Item Quick Inventory of Depressive Symptomatology (QIDS), clinician rating (QIDS-C), and self-report (QIDS-SR): a psychometric evaluation in patients with chronic major depression. Biol Psychiatry. 2003;54(5):573–583.
10. Kessler RC, Adler L, Barkley R, et al. The prevalence and correlates of adult ADHD in the United States: results from the National Comorbidity Survey Replication. Am J Psychiatry. 2006;163(4):716–723.
11. Kessler RC, Adler LA, Gruber MJ, et al. Validity of the World Health Organization Adult ADHD Self-Report Scale (ASRS) Screener in a representative sample of health plan members. Int J Methods Psychiatr Res. 2007;16(2):52–65.
12. Kessler RC, Adler L, Ames M, et al. The World Health Organization Adult ADHD Self-Report Scale (ASRS): a short screening scale for use in the general population. Psychol Med. 2005;35(2):245–256.
13. Weathers F, Litz B, Herman, D, et al. The PTSD Checklist (PCL): reliability, validity, and diagnostic utility. Presented at: The Annual Convention of the International Society for Traumatic Stress Studies; 1993; San Antonio, Texas.
14. Andrykowski MA, Cordova MJ, Studts JL, Miller TW. Posttraumatic stress disorder after treatment for breast cancer: prevalence of diagnosis and use of the PTSD Checklist-Civilian Version (PCL-C) as a screening instrument. J Consult Clin Psychol. 1998;66(3):586–590.
15. Adkins JW, Weathers FW, McDevitt-Murphy M, Daniels JB. Psychometric properties of seven self-report measures of posttraumatic stress disorder in college students with mixed civilian trauma exposure. J Anxiety Disord. 2008;22(8):1393–1402.