Raw Data Raw data consist of such items as a copy of a patient medical record or a pharmacy computer output. These should be obtained with patient consent and incorporated into the research record. In general, a record will be more accurate than a verbal report from memory. For interviews of the patient, family member, and prescribing psychiatrists, the treatment history form itself serves as the raw data, with a separate form completed for each individual interviewee for each episode of depression. Repeat interviews (eg, following remission of the acute episode) require completion of a new form. The more complete the information about the treatment received during an episode, the more accurate the characterization of treatment history and treatment resistance. For this reason, it is important to not simply interview patients about prior treatments, but to also obtain information from past treatment providers, pharmacies, and medical records. Treatment History Form The treatment history forms consist of a cover sheet and continuation sheets. One set should be used for each available source of information in a particular episode. A separate summary form is used for each episode to evaluate and collapse information from multiple sources.(Forms are available from HAS) Identifying information about the characteristics of a particular episode should be ascertained and recorded as accurately and in as much detail as possible. The DSM or Research Diagnostic Criteria (RDC) diagnosis, the designation of unipolar/bipolar and psychotic/nonpsychotic, and the duration of episode will be critical to later determination of the potency of treatment trials and the relative resistance to treatment. Criteria for assessing the adequacy of treatment vary with diagnosis (unipolar vs. bipolar or psychotic vs. nonpsychotic), and the determined duration of the episode establishes the time frame for evaluating the adequacy of treatment. For ECT, the possibility of recording detailed information, even though it may not always be available, has been incorporated into the form. Evidence of inadequate seizure duration should be explicitly noted.

For each medication trial, each change of dose and each blood level should be recorded on its own line. The purpose is to provide a time line for each trial of the alterations in oral dose and the documentation of blood levels. The date that blood was drawn for levels should be recorded, if available. The reason for stopping the trial should be identified, with particular reference to relapse after acute response, limiting side effects, lack of efficacy, and noncompliance. The final outcome of the trial and compliance with the prescribed regimen should be rated using the scales at the top of the form. In addition, it should be indicated whether each trial was conducted on an inpatient or outpatient basis. Rating Antidepressant Trials Each medication or medication combination should be considered separately and rated on the “Summary Form.” Information concerning ratings of specific agents is contained in the section “Criteria for Rating Medication Trials for Antidepressant Strength.” A score of “3” is the threshold for considering a trial adequate and the patient resistant to that treatment. Episodes designated as nonpsychotic can be rated without considering the antipsychotic equivalency scales. Note that lithium, lamotrigine, and carbamazepine have differing ratings for depressive episodes in unipolar versus bipolar patients. When blood levels are available for imipramine, desipramine, or nortriptyline, they take precedence in ratings relative to oral dose. Episodes diagnosed as psychotic depression (by DSM or RDC) should be considered in the following …