In the field of mental health, there is a discrepancy between how research is conducted and how care is delivered. WCG’s Clinical Endpoints group is collaborating with leaders in health care to bridge that gap by delivering solutions that optimize the time clinicians spend with patients and improve the quality of information gathered during their conversations.
Like other disorders of the central nervous system, mental health issues are difficult to diagnose and treat because there are few objective determinants of the
disease’s presence and severity. Clinicians can measure blood pressure using a cuff or test basic metabolic functions with routine lab work. But a patient’s mental state, including changes in mood, attitude or memory, are far more difficult to accurately measure and track.
In research settings, clinicians spend hours interviewing each volunteer. Using carefully designed questionnaires, they are trained in the methodology of collecting information about volunteers’ thoughts, feelings and symptoms, charting their changes over time to determine progress or worsening of mental states. WCG’s Clinical Endpoints team specializes in the development of measurement scales and in the training of scale administrators (called “raters”). Properly designed psychometric scales allow researchers to standardize the information they collect from volunteer to volunteer, and from each individual over the course of time. What emerges is a set of carefully collected data that, when analyzed, can indicate the presence or absence of behavioral syndromes, determine the severity of the condition, and track response to treatment.
The clinical care setting is quite different; although clinicians recognize the utility of psychometric scales and measures in characterizing, predicting and treating mental illness, most do not have the time required to conduct structured interviews with each patient. Also, in some facilities they tend to treat patients in urgent need who may be too impaired to participate in lengthy evaluations.
To improve both the conduct of research and the delivery of care, and in an effort to bridge the gap between the two, WCG has partnered with leading international psychiatric researchers to develop new, abbreviated tools to collect data in clinical settings.
One example is the PANSS-6, derived from the much longer 30-item standard version of the scale. To make the PANSS-6 and other scales more accessible, WCG worked with Drs. Søren Østergaard and Christoph Correll to co-author the SNAPSI, the Simplified Negative and Positive Symptoms Interview, which takes about
15 minutes to administer, and has been demonstrated to yield results equivalent to lengthier measures.
SNAPSI, an abbreviated measurement instrument, is both scalable and sensitive, meaning that it helps clinicians quickly measure disease severity as well as changes over time. It is designed to quickly allow clinicians to calculate scores for standard measures, including global evaluations of illness such as the Clinical Global Impressions Scale (CGI), overall mental state evaluated by items on the Brief Psychiatric Rating Scale (BPRS), and to test six core positive and negative symptom dimensions of schizophrenia and other psychotic disorders on the PANSS-6: Delusions, Conceptual Disorganization, Hallucinations, Blunted Affect, Passive/Apathetic Social Withdrawal and Spontaneity, and Flow of Conversation.
In addition to standard probes for delusions and hallucinations, the interview invites patients to describe their emotional states and includes a section on task sequencing, which provides a more powerful indication of disordered thought processes than observation alone. This assessment is comprised of two sections, the patient evaluation interview and a caregiver portion, which includes instructions for evaluating information provided by third-parties.
“The culmination of many years of clinical trial data, SNAPSI is the first tool we’ve developed that will directly improve the patient’s experience in clinical care, making critical items accessible for clinical practice from the CGI, PANSS-6, BPRS, and other scales. By introducing a better structured interview built for practical care, we will establish more realworld data, tracking a greater number of patients’ progress from baseline through treatment. We are very proud of this significant achievement, as well as the promise it holds for the future of mental health.”
Sofija Jovic, PhD, MBA
One of the biggest challenges in research is identifying potential participants, who are often discouraged by the amount of time required to participate. By introducing the abbreviated SNAPSI interview, WCG and their partners have helped lower the barrier to clinical trial participation in mental health. In the clinical care setting, time is always of the essence. In the United States, the top prescribers of psychotropic medication are currently the U.S. Department of Corrections and Primary Care Providers (PCPs). With SNAPSI, these providers, as well as other mental health professionals, will have access to an easy-to-use tool to evaluate their patients quickly and accurately, supervise them more effectively, and treat them with a greater degree of precision to dramatically improve outcomes.
WCG and collaborators have made SNAPSI freely available for non-commercial clinical and academic use.