By Allison Proffitt 

November 19, 2014 | PHT has released an electronic version of the Mini International Neuropsychiatric Interview (M.I.N.I.) for electronic data capture, and has developed training for the tool that will improve data quality and optimize the uniformity of clinician-reported data capture across clinical studies.

The M.I.N.I. is a structured diagnostic Q&A-style interview developed for DSM-IV, DSM-V and ICD-10 psychiatric disorders. PHT is the first to implement the electronic M.I.N.I. in a web browser based environment, the PHT NetPRO System, for use in global clinical trials. 

Most questionnaires originated on paper and are being migrated into the electronic capture environment, explained Susan M. Dallabrida PhD, Vice President, Clinical Science & Consulting at PHT, and she says the M.I.N.I was a perfect candidate. On paper, the scale is 29 pages and 381-questions long, with about 75 instances of “branching” in the questions: If answer A then ask question Y; if answer B, then ask question Z.

“What better place to put these lengthy and challenging instruments than in an electronic system… where [survey branching] can be taken care of behind the scenes?” Dallabrida said.

But putting a clinical interview like the M.I.N.I into an electronic format is not as simple as collecting patient-reported outcomes.

“This being a very comprehensive view of mental health, the rater scales in general are more complicated than a patient-reported outcome, because now we have to take all of the clinical variables into consideration.”

In order to make sure the electronic version of the M.I.N.I. has the same validity as the paper version, PHT worked with Dr. David Sheehan, developer of the M.I.N.I. The process began more than a year ago, Dallabrida said.

“This is the first time we’ve been able to… have a developer work with us on the electronic implementation, see what those differences are, and offer insight into the scale properties and scale integrity to ensure that all of that is met from a clinical perspective,” said Dallabrida.

In addition to vetting the electronic scale with Dr. Sheehan, PHT also designed a rater training program for the M.I.N.I. Administering and scoring a scale like the M.I.N.I. can be tricky, and variability among raters leads to wide variation in scoring, which can have safety and efficacy outcomes.

For example, a clinician may ask a subject if they are feeling depressed. The subject responds, No, but the clinician notices body language and hears a tone of voice that makes her doubt the answer. Does she enter “No” on the survey and move on? Or does she enter “yes” based on the body language? She should probe further, seeking examples, and helping the patient to reconcile their answers.

But that takes time.

“By talking about how to administer the scale, [PHT’s training] specifically deals with getting all of the raters aligned in how they administer the scale, and how they seek to get answers from the subject,” Dallabrida explains.

Rather than having clinicians focused on following branching questions and getting the paperwork right, PHT hopes the electronic M.I.N.I. will give them more time for their patients.

“Let’s have the clinicians focus on the patients and getting the right diagnosis, and not spend even five or 10 minutes of their time re-reading [form instructions and branching requirements],” Dallabrida said.

The electronic M.I.N.I. is available now in the PHT NetPRO system, and Dallabrida said that more long-form questionnaires are coming soon.