Data Management Q&A
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The genetics of obsessive-compulsive disorder remain a mystery. Are researchers getting closer to understanding what are the underlying triggers?Researchers are always getting closer to answers for the questions they
pose and study, often through the two steps forward, one, two, or three
steps backward method. That said, I do not believe we shall have better
clinically useful understandings of the genetics involved in the many
kinds of OCD presentations that exist for many years. OCD, and most
medical disorders, are genetically complex or multifactoral. -
What are some ways computer interviews of patients to gather cognitive data, particularly using IVR technology, can be expanded in the future?Cognitive functioning is typically assessed by asking questions that test memory, understanding and ability to perform mental tasks. Sophisticated cognitive function testing is typically done by a computer using a screen and keyboard, where questions appear on the screen and a person responds by pressing keys on the keyboard. Research over the past decade has shown that cognitive function assessment can also be done using the telephone as the computer terminal, by asking questions a person hears and responds to by pressing keys on the telephone key pad
or answering verbally, often by saying, “yes,” “no,” or with other short words or numbers. This telephone-computer method is called interactive voice response, abbreviated IVR, and familiar to all through many IVR systems in everyday use. Some of those systems are poorly designed and frustrating to use, but the cognitive function IVR programs are carefully designed and able to be used well even by individuals in early stages of dementia. Using IVR makes cognitive function assessment available any where there is a telephone including in people’s homes, so widespread screening for early changes in cognitive function becomes possible. Much follow-up cognitive function testing can be done conveniently at home rather than having to travel to the doctor’s office
for this purpose. -
Increased risk of suicide is a big concern in trials testing mood disorder drugs. What are the major challenges, both technologically and from a practical standpoint, for investigators and monitors in identifying potential patient-suicidality signals?The issue of suicidality (suicidal thoughts and/or behaviors) in relation to medications is challenging. Medications might increase or decrease suicidality. When suicidality increases with medications, the size of the increase is usually small, which makes it hard to identify. Decreases in suicidality would be a highly desirable attribute of medications, but very few medications have been found that have this desirable effect to date. Further complicating this issue is the finding that suicidality may be increased not only by antidepressants, but also by antiepileptics, as well as some drugs for smoking cessation, acne, asthma and allergy. Medications that have a direct or indirect effect on the brain through interactions with bodily chemicals could, theoretically, cause increased suicidality. Defining the magnitude of any such risks is part of the role of the Food and Drug Administration, just as FDA tries to identify any adverse effects of all medications to increase the benefit-risk ratio for patients receiving them. In summary, the small size of increased suicidality risk if any is present at all and the possibility that increases may occur in many classes of medications makes the identification of these risks and their magnitude difficult but important.
A person experiencing suicidal thoughts or behaviors is the best source of information about his or her thoughts and behaviors – occasionally additional information is available from others. Suicidality is stigmatized and people experiencing suicidality are often reluctant to reveal their thoughts and behaviors to clinicians. Some clinicians are also reluctant to ask patients about suicidality. Research over the past 35 years has consistently shown that people disclose more
suicidality in computer interviews than when asked the same questions by clinicians. Even when clinicians do their very best assessing suicidality, being human, they inevitably do it somewhat differently than other clinicians and even differently themselves from time to time. The inevitability of limited human assessment reliability puts an upper limit on the accuracy possible in any kind of assessment, including suicidality. Beyond problems of reliability, human record keeping is variable in accuracy, calculations, completeness, and legibility, problems computers largely overcome.For all these reasons, use of computer interviews to assess suicidality offer substantial advantages compared with human interviewers. The interviews are the result of careful composition of wording and branching by experts on suicidality, faithfully conduct each interview as an ideal human interviewer would, are accessible any time and any where a computer or telephone is available and store data in electronic data bases, where they can be used to alert clinicians of results and preserved for analyses as data accumulate. The goal of accurately identifying suicidality signals, positive or negative, is well-served by the use of computer interviews of patients at possible risk of
suicidality.



