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Empirical Method

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 one improve results in treating patients with psychiatric disorders? One way would be to measure the outcomes and compare different methods of treatment and see which method performs better. But how do we compare treatment methods? Before we commence on this road we have to know that we are treating the same diagnosis and utilizing an orderly standardized approach to both diagnosis and treatment. Although tools are available to academic researchers but how does an average psychiatrist do this. There is also the problem of subjective bias in both diagnosis and treatment approaches.

The reliability of psychiatric diagnoses using an open ended routine clinical psychiatric evaluation has been found to be low1. Studies evaluating the likelihood of agreement on diagnosis between 2 experienced psychiatrists (inter-rater reliability) ranges between 54 percent 2 and 63 percent 3. The three main reasons for diagnostic disagreement were: “inconstancy of the patient” (5%), “inconstancy of the clinician”(32.5%), and “inadequacy of the nomenclature” (62.5%)4.

We have criteria available in the form of Diagnostic and Statistical Manual of mental disorders. If we could convert the criteria into questionnaires and the questionnaires are administered to patients via a computer that would eliminate bias and reliability. We need to establish the degree of impairment in a numerical score so we can compare whether patients benefit from treatment and to what degree.

This requires that there is a standardized approach to treatment as well. This is easier to do in psychopharmacological treatment. Pharmaceutical companies establish the efficacy of drugs by using a standardized approach to measuring treatment efficacy. We could also use similar checklists to arrive at the conclusion whether a drug has efficacy in treatment of a certain disorder. But how do we compare drugs and which drugs are to be used first and which ones for second or third option. We can do that by establishing a protocol that suggests first line, second line and third line drugs. How do we choose which drug should be first line and so on? First line drugs should be most effective and with least side effects. This can be established by the risk benefit ratio: Number Need to Harm (NNH) : Number needed to treat (NNT). NNH is computed as 1/Event rate among exposed subjects-event rate among subjects not exposed. A low NNT means few patients need to be treated before one responds. There have been several attempts at establishing protocols that include TMAP (Texas Medical Algorithm Project), STAR*D, Step-BD and CATIE. There are published guidelines by APA and UK’s NIH and Canadian Psychiatric association. With these precedents it is possible to develop protocols that can be used to standardize treatment.

There are significant differences between algorithm based treatment vs treatment as usual approach. Katon et al5 reported response rates of 44% with treatment as usual group vs 74% of algorithm based treatment. Patients also endorsed algorithm based treatment as better quality of care 93% vs75%.

The problem of poor diagnosis and results in psychiatry is not new. An lnstitute of Medicine report on quality of health care (2001) recommended use of information technology by increasing the use of reliable questionnaires to assess and measure outcomes to build a database of effective treatments. These measures would provide a way to improve quality of care 6,7.

There is considerable and expected bias amongst experts paid by pharmaceutical industry to distort these protocols. Pharmaceutical companies have a profit motive so they are expected use ways to entice physicians to prescribe their drugs. Then there is the issue of cost of treatment. If a generic is as effective as a newly marketed drug then pharmaceutical industry would not want that to happen. Comparative efficacy studies if conducted by pharmaceutical funded physicians will result in bias favoring their drugs. Studies that do not show greater efficacy are unlikely to be published.A study by Sawka concluded that "industry sponsored research tends to draw pro industry conclusions”8. Silverman concludes that physicians cannot assess the value of information in the absence of studies from unconflicted sources 9.

If we are going to find out which treatments are most cost effective then we need to be able to do comparative efficacy with standardized diagnosis and treatment with outcome analysis.

SoftPsych has put in considerable effort to develop software that can be used by average psychiatrist to accomplish this task easily. Software screenshots will be used to demonstrate how to use the software to improve treatment efficacy. This is followed by other chapters that bring a psychiatrist up to date with analysis of current therapeutic approaches, indications and side effects of drugs and protocols to start on this empirical approach to treatment.

How the software works?

Diagnosis

Creating checklists can be helpful as demonstrated by Gawande in 35% reduction of deaths and complications related to surgery10. Psychiatrists believe the use of checklists would be off putting to patients who need the human touch and who will take the time to score the checklists. Checklists get detailed information and patients often reveal more to a uncritical screen than to a person. PsychPatient.com was developed to address the issue of collecting information with the least effort. Patients can be assigned history, diagnosis and degree of impairment questionnaires that they can complete at home or in the waiting room and results would be delivered to you instantly. Considerable time is now spent on data gathering with little time left to engage the patients in addressing their concerns, fears and barriers to treatment. Now you have the time to do just that. Provide patients with quality time that would enhance therapeutic alliance and improve outcomes. You can examine the questionnaires to focus treatment and enquire in detail about the problems they are experiencing.

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/PsychPatient.com

 


The results of the Adult screen are shown in the Fig. 2. It suggests a possible diagnosis of Major Depression.


Adult screen results

Fig. 2   PsychPatient.com

 

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. 3:

 

Major depression screen

Fig. 3   PsychPatient.com

The result from the questionnaire in Fig. 4 is a diagnosis of Major Depression:

Major depression results

Fig. 4  PsychPatient.com

We have now established the diagnosis and we know exactly which criteria were met for the diagnosis.

 

There can be little dispute about this diagnosis and its objectivity.

Treatment

Next step would be to determine the degree of impairment with a numerical score. We use Depression score, Fig. 5 is a screen from Menu Choices for Depression score:

Depression treatment menu


Fig. 5   Psychpatient.com/Depression Psychopharmacology

The next screen Fig. 6 is the questionnaire answered by the patient:


 

Fig. 6   Psychpatient.com/Depression Psychopharmacology

And the results of the screen are shown below in Fig. 7:

Fig. 7   Psychpatient.com/Depression Psychopharmacology

Now we have used an objective test and have come up with a numerical score of 14 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 Empirical Psychopharmacology/Depression Psychopharmacology or Psychopharmacology Suite by SoftPsych to make the decision to treat(Fig.8).





Fig.8   Empirical Psychopharmacology

Based on the Depression score, this is Moderate depression and the choices of treatment are shown below in Fig.9



Fig. 9  Empirical Psychopharmacology

Moderate depression can be treated with pharmacotherapy and the current guideline is suggested below in Fig. 10


Fig. 10   Empirical Psychopharmacology

How do we judge the response to medications? Fig. 11 below offers a guideline.

 


Fig. 11   Empirical Psychopharmacology

 

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. 11).

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 and the protocol at Softemr.com or SoftEMR Pro by SoftPsych.

(Fig. 12)

Fig. 12   Softemr.com/SoftEMR Pro for Mac/Windows

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. 10):

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:

    1. Assess progress by comparing the scores over time?

    scores

    Fig. 13   Softemr.com

    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.

    2. Comparative Efficacy

    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?

    Fig. 15   Softemr.com

    In the above example(Fig. 15), Fluoxetine is compared to 3 drugs 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.

Conclusion

Psychiatrists can now use this data to have their own analysis. We can improve treatment efficacy, reduce unnecessary and excessive treatment with its attendant harm and reduce cost.

Why? How?  Advantages,  Benefits,  Videos

  • Why?
  • How?
  • Advantages
  • Benefits
  • Videos

Top

  1. I can find all this in any textbook, so what’s new?
  2. Why should I do checklists and Diagnosis Scores that is only for Researchers not Clinicians?
  3. I can get all this treatment information by reading research articles?
  4. Researchers may find this software useful but what is its relevance to an average Clinician!
  5. Who will enter all this data and it would be very time consuming?
  6. You are implying that I can get an Accurate Diagnosis, Not Miss co-morbid disorders, use Current Interventions and improve my Outcomes in 25 minutes or less!

I can find all this in any textbook, so what’s new?

  • Textbooks are very expensive and it takes a long time to find information you need. SoftPsych programs give you information quickly and easily with a few Clicks. Let us take the example of a common diagnosis like Major Depression: You can read a textbook to find the criteria for a diagnosis but do you know exactly which questions to ask and whether the Criteria of a diagnosis have been met or not. SoftPsych allows you to Confirm a Diagnosis in less than 5 minutes with questions in your Handheld(PDA) or Computer. You can also Screen for common disorders in 10 minutes and not miss any co-morbid disorders. Let us take another example of ADHD, you can not only confirm an Accurate diagnosis but get a Numerical ADHD Score that allows to monitor progress of the patient. You can get an Accurate diagnosis and a Numerical Score in less than 25 minutes.
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Why should I do checklists and Diagnosis Scores that is only for Researchers not Clinicians?

  • Checklists give you an accurate diagnoses and an Objective method of establishing a Diagnosis. You can justify your Diagnosis that meets established criteria to Quality Assurance or Insurance companies. You can measure progress or lack of it using Objective criteria that are used by Researchers. Checklists and scores can be obtained in a matter of minutes and do not require the time of a busy clinician. The tests can be administered by a secretary or non-professional. The interventions or medications we use now were also approved on the basis of these very checklists and Scores. Now you can use the same tools available to researchers at a fraction of cost and time. The data analysis is also more specific to your population of patients and not based on patient groups in an academic setting. You can use more effective interventions confidently and get better results.
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I can get all this treatment information by reading research articles?

  • Most clinicians are pressed for time and can not keep up with the most current information or have the time to compare different articles in various journals. How many clinicians have actually read the Texas Algorithm Project(TMAP) or CATIE or STARD*? Let us assume you have actually read them but do you have the time to summarize the data in a quickly accessible format? SoftPsych software does all this work for you and gives you the salient features in a format that is accessible in seconds!
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Researchers may find this software useful but what is its relevance to an average Clinician!

  • Let us use one example from Professional sports, what would be state of Professional sports if they had no access to Video or Instant replay?
    Let us use another example, You would like to Buy a Stock or Mutual Fund but you don’t know which one or you know which Stock or Mutual fund to buy but you do not know how it compares to other Stocks or Mutual funds. You go to Internet websites like Yahoo. You can now do the analysis of Stocks or Mutual funds based on their History, growth rate, past performance etc. Now you have more objective data to help you arrive at a decision using Objective Criteria.
    This same analysis can also be done now with our own database of patients. You can check to see Which age group, demographics or Diagnoses respond better to which Medication or Intervention. This analysis will allow you to provide more effective care to your patients based on an Accurate Diagnosis.
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Who will enter all this data and it would be very time consuming?

  • The data entry is minimal and no more than you do already. You have to enter patient’s demographics, Diagnosis and Interventions in your records. The data entry is simplified by giving you Drop down boxes and the entry is accomplished in a few minutes and the system can now Query this database for your analysis. This data entry can also be done by a non-professional from your current paper based records.
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You are implying that I can get an Accurate Diagnosis, Not Miss co-morbid disorders, use Current Interventions and improve my Outcomes in 25 minutes or less!

  • That is correct. The initial visit will take 25 minutes (or less depending on the number of Checklists) and subsequent visits may be even less than that.
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How can SoftPsych Software benefit institutions like Mental Health Clinics and Hospitals?

  • Accurate diagnosis with documentation
  • Computerized Psychiatric history, treatment plan and progress notes
  • Substantial increase in productivity
  • Logical, coherent psychopharmacology that maintains continuity of care

Mental health professionals are pressed for time in which they have to be able to make an accurate diagnosis, discuss its implications, and do the paper work.This often leads to sloppy work in which either the diagnostic process or contact with patient suffers.
What if you could obtain an accurate diagnosis in less than 10 minutes and have the documentation to support the diagnosis? All this can now be accomplished with SoftPsych software Athena and Zeus.

History and treatment plan can now be almost automated. We provide checklists to collect the data. A list quick dropdowns for Mental status and treatment plan. You have now quickly developed and written history and treatment plan.

SoftPsych has developed EMR software that can record History and progress notes.Most institutions have several psychiatrists that provide care. Each psychiatrist has his/her own biases in treatment choices. Follow up by different psychiatrists can be problematic. There are no agreed upon ground rules for managing different disorders. There is no way to provide consistent care or measure progress. Some institutions have protocols to treat different disorders while most do not. Protocols are time consuming to develop and difficult to maintain.
Consider the possibility that all patients can be managed by one protocol that is instantly accessible on a computer and measurable numerical score to assess progress. Any psychiatrist can see what steps have been taken and which steps are to be taken next. Now the patients can receive care that is consistent and predictable. The psychiatrists can change but the delivery of care remains consistent and predictable.


Psychopharmacology software developed by SoftPsych allows you to accomplish all these ideals with a minimum of fuss.Psychopharmacology Software for major disorders of depression, ADHD, Anxiety and psychosis are available that provide:
 

  • Checklists to establish a Numerical score for each disorder that can be recorded
  • Standardized protocols are available for major psychiatric disorders
  • Consistent care across changing professionals Measurable progress

Advantages of using SoftPsych Software in your daily Clinical Practice

  •  Stay Current with Research and Guidelines

We are all busy and have little time to read up on all the new research and guidelines that come out. SoftPsych performs this review for you and provides current data on Medications and interventions regarding those that are the most effective.

  • Instant Access to useful information

Get on top of protocols, treatment and medications available within seconds. It’s as easy as using your computers basic functions or your Handheld device (PDA- iPhone,iPad, Android or Blackberry).

  • Data Analysis increases your Effectivenes

Computers today allow us analyze the effectiveness of our interventions instantly. We can tell which interventions and medications are most effective with which Diagnoses and treatments.  Provide measurement based, cost effective care.
 
You now have the tools of a researcher available at your fingertips! Just imagine where professional sports would be today if they could not review Videos of their own (and their opponents’) games!  See SoftEMR Pro


 

 

How can SoftPsych Software benefit institutions like Mental Health Clinics and Hospitals?

  • Accurate diagnosis with documentation
  • Computerized Psychiatric history, treatment plan and progress notes
  • Substantial increase in productivity
  • Logical, coherent psychopharmacology that maintains continuity of care

Mental health professionals are pressed for time in which they have to be able to make an accurate diagnosis, discuss its implications, and do the paper work.This often leads to sloppy work in which either the diagnostic process or contact with patient suffers.
What if you could obtain an accurate diagnosis in less than 10 minutes and have the documentation to support the diagnosis? All this can now be accomplished with SoftPsych software Athena and Zeus.

History and treatment plan can now be almost automated. We provide checklists to collect the data. A list quick dropdowns for Mental status and treatment plan. You have now quickly developed and written history and treatment plan.

SoftPsych has developed EMR software that can record History and progress notes.Most institutions have several psychiatrists that provide care. Each psychiatrist has his/her own biases in treatment choices. Follow up by different psychiatrists can be problematic. There are no agreed upon ground rules for managing different disorders. There is no way to provide consistent care or measure progress. Some institutions have protocols to treat different disorders while most do not. Protocols are time consuming to develop and difficult to maintain.
Consider the possibility that all patients can be managed by one protocol that is instantly accessible on a computer and measurable numerical score to assess progress. Any psychiatrist can see what steps have been taken and which steps are to be taken next. Now the patients can receive care that is consistent and predictable. The psychiatrists can change but the delivery of care remains consistent and predictable.


Psychopharmacology software developed by SoftPsych allows you to accomplish all these ideals with a minimum of fuss.Psychopharmacology Software for major disorders of depression, ADHD, Anxiety and psychosis are available that provide:
 

  • Checklists to establish a Numerical score for each disorder that can be recorded
  • Standardized protocols are available for major psychiatric disorders
  • Consistent care across changing professionals Measurable progress