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Research to Practice

simply get the facts and essentially


to “give no help” in order to
minimize the placebo response. This
distinction between clinical and
research interviews reflects the very
real difference between
psychotherapy that seeks clinical
benefit and assessment procedures
for conducting research. Research
protocols attempt to minimize any
extraneous factors that could
impact the assessment of an
experimental treatment. Clinical
improvement gained as a result of
the interview process is one
possible factor that could obscure
the assessment of relevant
symptoms or behavior during the
course of a clinical trial.
The contrast between seeking
hard facts for research versus
seeking therapeutic benefit for the
patient can be a challenging issue
for new research interviewers
(raters), who are often trained in a
THE DISTINCTION BETWEEN CLINICAL clinical tradition. This article
provides a brief review of the
AND RESEARCH INTERVIEWS rationale and justification
underlying the focused, neutral
IN PSYCHIATRY interview style that is required in
clinical research.
by Steven D. Targum, MD PSYCHIATRIC INTERVIEWS:
THE SETTING DETERMINES
Innov Clin Neurosci. 2011;8(3):40–44 THE STYLE
To better understand the marked
distinction between psychiatric
interviews done in clinical practice
ABSTRACT KEY WORDS and research-specific interviews, it
Research interviews require a Research interviews; structured is necessary to review the intended
fact-based, neutral inquiry style that interview guides purpose and process of a psychiatric
contrasts markedly from the interview that is done in clinical
empathic style of clinical interviews INTRODUCTION practice.1
in psychiatric practice. In fact, the Clinical researchers in psychiatry In clinical practice, a psychiatric
research interview generally seeks are usually trained as clinicians interview is intended to do more
to gather information and before they begin to do research. In than merely gather information.
specifically avoid any therapeutic clinical circles, the oft-cited credo Generally, the first interview is the
benefit. This article describes the to “do no harm” to the patient also beginning of a process meant to
purpose of these opposing interview implies some effort to provide some engender therapeutic benefit for the
styles and provides some guidelines help as well. In contrast, the patient. The interviewer attempts to
for beginning clinicians conducting primary objective of the properly establish rapport and trust with the
research. conducted research interview is to interviewee (patient) in order to

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put him or her at ease and to opposed this question-and-answer styles that foster empathy and
facilitate an open and honest technique and asserted that it reassurance or interviews that are
communication about psychiatric cannot work to assess, “a person’s confrontational or upsetting to the
symptoms and difficulties in living. assets and liabilities in terms of his patient are inappropriate in a
The initial interview generally future living.”2 He also noted that research setting. Sullivan’s goals for
proceeds with open- and closed- the patient comes to the interview patient improvement through the
ended questions, which are meant with some expectation of interview process are clearly
to obtain clinical history and current improvement or other personal gain contradictory to the objective of the
symptoms and to yield a diagnostic from the experience. These high research-based interview.
formulation and development of a expectations can be useful to Furthermore, Sullivan’s reason for
treatment plan. Throughout the motivate the patient toward clinical opposing the question-and-answer
interview, the interviewer uses improvement. An essential part of technique for clinical interviews
direct questioning, empathic the interview process according to may be exactly why it is useful in
listening, paraphrasing of the Sullivan, and many others, is to research interview settings. Clearly,
patient’s words, reflection, achieve some therapeutic benefit. the question-and-answer interview
interpretation, and summation to Thus, the objectives of the style is more of an investigative
clarify the information. Some psychiatric interview in clinical (interrogative) process rather than
psychiatric interviews may include practice are to conduct a diagnostic a therapeutic approach to a
positive reinforcement and and symptomatic assessment psychiatric interview.
reassurance to foster the process as well as to seek a The clinical information about
“therapeutic alliance” and sustain therapeutic benefit. symptoms and behavior obtained
the collaboration. Some interviews The objective of a psychiatric during the psychiatric interview is
may even be confrontational in interview in clinical research is very often subjective. The clinical
order to get the patient to better different from interviews conducted information is generally based on
examine his or her own ideas or by clinicians in clinical practice.3 the patient’s report and cannot
statements.1,2 The research interviewer still always be corroborated. An open-
Harry Stack Sullivan was a attempts to establish rapport with ended interview style that does not
brilliant pioneer in the elaboration the patient and to be interactive focus on specific questions, and
of the psychiatric interview process. throughout the interview in order to answers may not generate the
He used an interactive and obtain accurate clinical information. clinical information necessary to
sometimes confrontational interview However, the research interviewer complete an accurate research
style. In fact, he commented, “I do intentionally maintains a relatively interview. Therefore, both the
not believe that I have had an neutral attitude without making validity and reliability of the
interview with anybody in 25 years judgments, therapeutic interview will be at risk.
in which the person to whom I was interventions, or offering Validity of the interview refers to
talking was not annoyed during the reassurance or advice. Therapeutic whether the data obtained about the
early part of the interview by my benefit is definitely not an objective illness, the symptoms, and the
asking stupid questions.”2 Sullivan’s of the research interview. It has impact on function appear to be well
style was based upon a concept of even been suggested that different founded and accurately correspond
the expert-client relationship in interviewers, or even remote to how the disorder might present
which the goal was for the patient to interviewers, should be used at each in the real world. There are
leave the interview with some visit to avoid a potential therapeutic numerous factors that can influence
“measure of increased clarity about alliance that might foster clinical the validity of the interview.
himself and his living with other gain. In fact, patients who improve Some patients may be unable to
people.” In contrast to his own from the interview process are give a valid interview. They may be
interview style, Sullivan described a subject to placebo responses that uncooperative or defensive,
one-sided interrogation in which can and do adversely affect clinical uncomfortable in the interview
questions are asked and answered trial outcomes. Therefore, the high setting, or too ashamed to be honest
without any attention given to the expectations of the patient that may in their responses. Some patients
subject’s insecurities and no clue be useful in clinical practice are not may lack awareness of their
given to the meaning of the encouraged in a research interview. symptoms, have cognitive deficits,
information elicited. Sullivan Consequently, supportive interview or have distorted views that

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[RESEARCH TO PRACTICE]

TABLE 1. Key components for conducting a research interview the development of structured
interviews to improve the precision
• Interviewer Introduces him/herself to the patient of psychiatric assessments.4,5
Recently, the use of structured
• Establishes rapport (e.g., trust, engagement) clinical interviews for diagnostic
assessment as well as for
• Sustains neutrality throughout the interview symptomatic measurements have
become commonplace in clinical
• Explains the purpose of the interview
trials as well.6–8 The format and
specific questions contained in the
• Obtains verbal consent to proceed
structured interviews offer a tool to
regulate the style of the interview
• Explains the need to be as objective as possible
and to assure collection of sufficient
information for accurate scoring.
• Indicates the time frame for response to each question (e.g., 7 days)
The individual items of the
• Asks concise questions that are related to each item or sub-item interview guides contain fact-based
a. Uses the structured interview guide and very concrete queries intended
b. Asks questions that address anchor points for rating instrument to collect specific clinical data in
c. Asks additional questions if necessary to get sufficient information for accurate order to answer very specific
scoring questions. The objective, focused
nature of the research interview
• Seeks additional clarification whenever necessary improves the precision of ratings
and minimizes the use of a more
• Avoids leading questions or a rush to judgment open-ended or supportive style that
could foster therapeutic benefit for
• Summarizes the patient’s response to confirm accuracy the participating patient. The
restricted expressive range of the
fact-based, structured (question and
influence their responses. There are marked variations in the validity and answer) research interview
patients who will intentionally reliability of the collected data. For minimizes the potential placebo
misrepresent their responses in instance, reliance on open-ended responses that could adversely
order to inflate or decrease the questions alone may lack specificity affect signal detection.
apparent severity of their (e.g., “How have you been feeling Table 1 lists some of the key
symptoms. lately?”) that affects reliability components necessary for ratings
Similarly, some interviewers may between different raters. competency when conducting a
be unable to conduct a valid Alternatively, closed-ended structured research interview.
interview. The interviewer may have questions may be able to quantify, Similar to clinical practice, it is still
biases about the patient, the but might fail to identify less necessary to establish rapport and
research, or the specific treatment obvious, or hidden, clinical earn trust with the patient in order
intervention that influences their information (e.g., paranoia). to conduct a competent research
scoring. Other interviewers may The use of structured interviews interview. A lack of rapport will
simply lack the clinical experience for clinical research purposes has diminish the ability of the
or the interviewing skills necessary evolved, in part, to respond to the interviewer to obtain sufficient and
to establish rapport with a patient need to improve the validity and honest clinical information to score
and to elicit accurate information reliability of the clinical data accurately. As an example, Lipsitz et
for precise scoring. obtained. al3 describe lack of rapport as when
Reliability refers to how the the interviewer reads a question
clinical data collected about the STRUCTURED CLINICAL that has just been answered in
same patient by different INTERVIEWS IN PSYCHIATRIC another context without even
interviewers compare with one RESEARCH acknowledging it.
another. As noted previously, Many clinical researchers have The interviewer needs to sustain
different interview styles can cause contributed to the long history of a neutral attitude throughout the

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interview while being an active of the structured interview format including the potential for high
listener, must not rush judgments, improves inter-rater reliability even placebo responses. Most patients
and must avoid asking leading in multinational studies employing enter clinical trials because they
questions to force the response. An numerous countries and multiple have expectations about the benefit
interviewer with a neutral attitude languages. they will achieve from their
can still be engaged in the process On the other hand, it is obvious participation. Clinical interviews
of the interview. In fact, maintaining that a lack of ratings competency that foster warmth and reassurance
a neutral attitude does not mean causing scoring inconsistencies may inadvertently generate clinical
that the interviewer is either a might adversely affect the trial improvement related to these
disinterested or rigid. outcome. Ratings competency expectations that are unrelated to
Most structured interview guides includes both the demonstrated the experimental treatment being
anticipate some amount of open- ability to score accurately (ratings studied. The research interview is
ended questioning prior to the reliability) as well as the possession definitely not a therapeutic
initiation of the specific probe of adequate interviewing skills to interview, and therefore, every
questions used for each interview actually conduct the interview. In effort to restrict clinical benefit
item. We recommend that the one study, Kobak et al10 compared accrued during the interview
interviewer explain the purpose of the clinical trial outcome based process is warranted. The
the interview and obtain the upon the assessment of ratings structured research interview is
patient’s consent each time the competency. There were 34 raters designed exactly for the singular
interview is conducted in order to who were distinguished as either purpose of collecting the facts.
assure consistency and to confirm good-to-excellent raters or poor-to- Thus, there is a marked, necessary,
that the patient is still willing to fair raters based upon the rater and understandable distinction
participate. It is sometimes helpful applied performance scale (RAPS).3 between clinical and research
to explain that the interview is, in In a study comparing paroxetine to interviews in psychiatry.
fact, structured by design to ask placebo in patients with major
specific questions and that lengthy depressive disorder, the overall REFERENCES
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O PP RR AA CC TT II CC EE ]]

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structured interview guide for the Psychiatry. 2005;162(3):628. Within the past two years, Dr. Targum has
Hamilton Anxiety Rating Scale done consulting for Acadia, Affectis,
(SIGH-A). Depress Anxiety. AUTHOR AFFILIATIONS: Dr. Targum is a AstraZeneca, BioMarin, BioVail, BrainCells
2001;13(4):166–178. consultant for the Department of Psychiatry Inc., CeNeRx, Cephalon, Cypress, CTNI
8. First MB, Spitzer RL, Gibbon MB, at the Massachusetts General Hospital. Dr. MGH, Dynogen, EnVivo Pharmaceuticals,
Williams, JB. Structured Clinical Targum is on the editorial board of Euthymics, Forest Research, Functional
Interview for DSM-IV-TR Axis I Innovations in Clinical Neuroscience. Neuromodulation Inc., Johnson and
Disorders, Research Version, Johnson PRD, Inc Research, Novartis
Patient Edition (SCID-I/P). New FINANCIAL DISCLOSURES: Dr. Targum is Pharmaceuticals, Novartis Bioventures,
York: Biometrics Research, New Scientific Director, Clintara, LLC; Executive Nupathe, ProQuest, Sunovion, Targacept,
York State Psychiatric Institute; in Residence, Oxford BioScience Partners, TauRx, Third Rock Ventures, and Wyeth
November 2002. Boston, Massachusetts; Consultant, labs.
9. Williams JB, Kobak KA. Massachusetts General Hospital,
Development and reliability of a Department of Psychiatry, Boston, ADDRESS CORRESPONDENCE TO:
structured interview guide for the Massachusetts; Chief Medial Advisor, Prana Dr. Steve Targum, 505 Tremont St., #907,
Montgomery-Asberg Depression Biotechnology Ltd, Melbourne, Australia; Boston, MA 02116; E-mail:
Rating Scale (SIGMA). Br J Chief Medical Officer, Methylation Sciences sdtargum@yahoo.com
Psychiatry. 2008;192(1):52–58. Inc., Vancouver, BC, Canaca. Dr. Targum has

44 Innovations in CLINICAL NEUROSCIENCE [VOLUME 8, NUMBER 3, MARCH 2011]

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