
Empirical method
is a scientific concept that suggests that the information is gained by means of observation, experience or experiment. The evidence derived by observation alone should be the measure of using a technique or method. How can this be applied to the field of psychiatry?
Diagnosis
Psychiatrists believe they know diagnosis and treatment just because they have been doing it all of their life. Let us put it to a objectivity test. What are the criteria you use to diagnose? The response usually is: DSM IV.
Can you tell me which criteria were met the last time you diagnosed the patient? Can you tell me which criteria the patient still meets? How do I know from your notes which criteria were met? Do you use a standardized questionnaire? Do you ask every patient the same questions?
The problem here is that no one knows which questions were asked and whether the criteria were met or not for a diagnosis. However if you could ask every patient the same questions and have a print out in the chart; your reasoning would have the support of objective evidence.
Is there a way to establish diagnosis that can pass this test? We are familiar with the concept of criteria that are used for a diagnosis. If the criteria can be transformed into questions then we can standardize the process of establishing a diagnosis. If every patient is asked to answer the same questions to arrive at a diagnosis then we know the process is Empirical evidence of a diagnosis. This process would not have the examiner’s bias. How would you accomplish this for every diagnosis and how can we ask so many questions that are pertinent to each diagnosis? The answer is simple, use a screening questionnaire not unlike doing a Comprehensive lab first and then zeroing in on the pertinent results for more specific tests. Is this possible? The answer is yes. Diagnostic software, Athena or Zeus Suite by SoftPsych1 provides just what is needed. Here are some examples using screenshots from the software. The first screen(Fig. 1) shows the choice of utilizing a screen for adult, child or parent:
Fig. 1 Zeus for Windows
The results of the screen are shown in the Fig. 3. It suggests a possible diagnosis of Major Depression.

Now we can zero in on this possibility and do a full diagnosis check up for Major Depression by using another set of questionnaire. Patient checks the answers that apply. Fig. 4:

The result from the questionnaire in Fig. 5 is a diagnosis of Major Depression:

We have now established the diagnosis and we know exactly which criteria were met for the diagnosis (Fig. 6). We can print out the results and keep them in the patient’s file for a retest later.

Fig. 6 Print out from Zeus for Windows
There can be little dispute about this diagnosis and its objectivity.
Treatment
The problem with follow up visits is the same too. The patient states she is not feeling better so you add another prescription. What is objective about this process? Could it be that patient is feeling better or worse for reasons that have to little to do with what is being treated? In the absence of standardized checklists (addressing the particular illness) you are operating blind. You have no way to measure the progress or lack of it. This practice is akin to practicing medicine before Lab and imaging studies. What would you call an internist who claims to treat Diabetes without ever getting Blood Glucose levels?
Drug manufacturers use a scientific method to assess whether a particular drug has efficacy for that disorder. Check lists are developed and patients are given the questionnaires to assess whether they are improving or not. We will also be using the same method to assess our patient’s progress. Fig. 7 is a screen from Menu Choices for Depression score:

The next screen Fig. 8 is the questionnaire answered by the patient:
And the results of the screen are shown below in Fig. 9:

Now we have used an objective test and have come up with a numerical score of 13 out of possible 27. We can use this test over time again to assess whether the patient is responding to our efforts.
We will now use Depression Psychopharmacology or Psychopharmacology Suite by SoftPsych to make the decision to treat(Fig.10).
Fig.10 Depression Psychopharmacology for iPhone/iPad
The software suggests that the first choice would be any SSRI(Fig.11).

Fig. 11 Depression Psychopharmacology for Android
We can also check the side effects and dose of each SSRI and the better choice to be made given the particular patient. Fig. 12.
Fig. 12 Depression Psychopharmacology for iPhone/iPad
Let us suppose that you do indeed use checklists to diagnose and measure treatment efficacy. Do you follow any standard protocols so another psychiatrist can follow your rationale for treatment? Consider Breast cancer. Is Stage 1 treated the same way as Stage 4?:
We follow the method in Fig. 13:
We have a clear guideline that tells us how to measure the patient’s response. A Nonresonse is a score above 9, partial response is a score of 6-8 while a remission is considered if the score is below 5 (Fig. 13).
Why bother using protocols? Psychiatrists are using their experience and intuition in determining what is best for their patients. Why would you want to restrict their choices by tying their hands? Such efforts would only restrict their creativity.
Each psychiatrist likes to use his pet medications and changes the prescriptions written by a previous psychiatrist or simply adds the ones he likes. Does the psychiatrist have any objective evidence to prove his choices are better?
Following a protocol establishes that you are using an orderly approach to treatment that can be followed by any psychiatrist with ease. If a patient has a documented diagnosis with a numerical score of the degree of symptoms (depression, psychosis, hyperactivity or anxiety), then you know the severity of the illness, treatment used, the effectiveness of treatment. It is also clear which approaches have already been used and which ones are still available.
A 10-15% improvement is seen in patients who are treated with guidelines and measurement based approach as compared to treatment as usual.3
We can record the patient’s score and medications in a record that can be viewed later. Here is an example of recording the score in the software SoftEMR Pro by SoftPsych. (Fig. 14)
The electronic record can be easily searched by patient’s visit date or name. The medications and the corresponding score can be seen easily.
What if the patient does not respond? Is there a way to choose the next treatment option? We can follow the Depression protocol(Fig. 15):
This protocol now provides a uniform way of addressing patients that are resistant to initial attempts. In a clinic setting where psychiatrists may change or in a group practice where several different psychiatrists may be following patients, an orderly manner of progression through various choices are provided. It is easy to know where the patient is depending on the LEVEL. The psychiatrists can change but the uniformity of treatment will remain.
This sample discussion demonstrates the Empirical method in practicing psychopharmacology. Each step is used based on the evidence provided directly by the patient using standardized questionnaires.
Outcome Analysis
How can this method result in better care? We can subject the data we collect to analyze various possibilities. For example:
- Assess progress by comparing the scores over time?
- Which patients are on SGA(Second Generation Antipsychotics) and are overweight?
- Is the newer more expensive drug more or less effective? This process can be used to find out which drugs are more effective with your patients? Are 3 drugs better than one?
- Which patients with Substance abuse diagnosis are prescribed benzodiazepines?
- What is the cost of prescriptions?
- Average cost of prescriptions by doctor?

The goal is to achieve remission. In this case of Depression the goal would be a score below 5. The goal may or may not be achieved but the performance is clear. This clarity of a goal and recording objective measures can be the basis of assessing performance of treatment methods.

The patients with elevated BMI and a prescription of SGA can now be easily identified. Medications can be changed and recommendations made to patient regarding their diet and exercise and medications to address elevated lipids or Diabetes.
Comparative Efficacy

Fig. 18 SoftEMR Pro
In the above example(Fig. 18), Prozac is compared to Fluoxetine using Depression score.The same process can be used to compare any number of antidepressants. Any two or more drugs can be compared if you are using the same diagnosis score.

Why is this relevant? It is quite common to see the excessive and inappropriate use of Benzodiazepines. A study reported non-medical uses of benzodiazepines has increased by 82% from 2004 to 2008. The main contributors were alprazolam (125%), clonazepam(72%), diazepam(70%) and lorazepam(107%).Estimated number of visits to Emergency for alprazolam in 2008 was 104,800,8. 44 million prescriptions were written for alprazolam in 2008.

Little attention is paid to the cost of treatment in the mental health system. Prescriptions are paid for by insurance or Medicaid/Medicare. Both the doctor and the patient know little about the cost of these medications. Do we pay attention to the cost of medications and whether the “new drug” is worth the extra expenditure?


Here you can see a large difference in prescribing practices of 2 doctors. Dr. Jones has an average prescription cost of 667.91(Fig. 22)compared to Dr. Smith (Fig. 23) with an average of 831.99.
The problem is that the psychiatrist is unaware of the cost of prescriptions. If they are provided with an intelligent electronic medical record (EMR) that shows the cost of prescriptions then they will know the cost of their treatment choice.
7. Polypharmacy

Fig. 24 shows a screenshot of a patient on 2 antipsychotics: Zyprexa and Abilify. Polypharmacy in Schizophrenia is estimated to be 3% to 71% with average from 10% to 40%13. There is little evidence to support the use of polypharmacy or augmentation14,15. Short-term treatment with multiple antipsychotics can cause increased adverse events, increased expense and no gain in clinical benefit16. Long term augmentation with SGA in OCD patients shows no improvement compared to just SSRI17.
Conclusion
Psychiatrists can now use this data to have their own analysis regardless of what the experts or pharmaceutical companies say. You can also find a more cost effective solution. One could say this is as good as the sport teams doing statistical analysis on which baseball hitter is likely to perform better against which pitcher or a replay analysis used by most professional teams.
The empirical method has been shown above with a simple example of depression.
The software by SoftPsych is available on Windows, iPhone/iPad, Mac, Android and Blackberry platforms.
References:
Empirical Psychopharmacology










