CDEPRO Institute International

A division of London Consult & Human Studies Center, Ltd.

The State of the Art
Information & Knowledge
Consultancy to Worlds of All Sizes ^sm

Behavioral Medicine Structured Interviews

The The Human Studies Center and London Consult assessment approach involves a multi-modal – interdisciplinary approach that is specifically designed for each project and need. Our clinical and research experience has shown that a modular approach is best. In addition to using a range of published instruments, we have also developed some validated behavioral medicine structured interviews. The instruments can be administered by the following methods:

1. Oral Interview

1. Conducted by a health professional
2. Data used for clinical impressions

2. Paper – Pencil

1. Completed by subject
2. Completed by professional

1. Data faxed for scoring
2. Data emailed for scoring

3. Computer

1. Administered by computer
2. Scored by Computer program

4. On-line Administration

1. Administered on-line
2. Scored on line

Why a New Set of Instruments?

A thorough review of the clinical and research literature related to assessment and measurement and quality of life measures in the areas of medicine, pain, behavioral medicine, medical psychology, psychology, and sociology reveals several current problems.

1. The vast majority of the research revealed that most studies rely heavily on self-report and questionable scales.
2. The majority of the data is based on antidotal report.
3. There are little inter-rater reliability measures.

Research in the field of behavioral medicine reveal that such sources have a tendency to perceive:

1. Lower levels of depression
2. Higher levels of anxiety
3. Higher interpersonal sensitivity than do the subjects [patients] themselves
4. Psychological symptoms and syndromes as situational and adaptive.
5. The intensity of a symptom more than the number of symptoms or their effects.

Most of the available instruments:

1. Ignore using subject goal accomplishment measures.
2. Reinforce a cognitive focus on the experience and thus emphasize the negative experience rather than a balanced appraisal of the drug effect.
3. Attempt to force the subject to attempt to translate feelings [an affective process] into words [a cognitive process].
4. Use selected words that have meanings that are not always clear.
5. Use word interval categories that do not represent identified steps in pain intensity.
6. Produce an artificial augmentation of the drug effect.
7. Have no documented reliability or validity.

State of the Art Considerations

The The Human Studies Center and London Consult instruments are based upon a comprehensive review of the state of the clinical and research data from a variety of fields. The multidisciplinary areas include the following:

Basic Instruments

The basic modules address a range of clinical research concerns. While the material is comprehensive, they require little patient / subject time to complete. The specific instruments are as follows:

1.  Complete Medical History

1. Patient / Subject
2. Family/ Significant Other history

2. Intake Evaluation

1. Background
2. Course of illness
3. Psychosocial History
4. Treatment History and Results
5. Level of Disability
6. Quality of Life

3. Treatment Effect

1. Physical Effects
2. Psychological Effects
3. Quality of Life Effects
4. Side Effects

4. Significant Other Evaluation

1. Another’s evaluation of treatment Effect
2. Data on Treatment Impact on Interpersonal Behavior

5. Specialized Instruments

(i)  Cognition

1. Intake Evaluation
2. Treatment Effect
3. Significant Other Evaluation

(ii)  Pain

1. Intake Evaluation
2. Treatment Effect
3. Significant Other Evaluation

Rating Methods Used

The response sets for the modules include open and closed ended questions that address distress and intensity issues. The specific response types include:

General Data Topics

The modules provide the clinician / researcher / with state of the art data. The general topics include The following:

Specific Data Points Topics

The London Structured Interviews systematically and reliably collect essential data. The specific issues include:

1.  Behavioral Medicine Issues

1. Litigation Involvement
2. Depression
3. Anxiety
4. Somatization
5. Secondary Gain and Other Syndromes

2. Behavioral Issues

1. Behavioral Changes
2. Social Interaction Effect
3. Goals
4. Quality of Life Issues
5. Condition Evaluation

3. Condition Rating

1. Activities
2. Interference
3. Behavior
4. Effects

4. Condition Effects

1. Medical
2. Psychosocial
3. Mood
4. Goal Accomplishment

5. Medical Effects

1. General Health Issues
2. Specific Symptoms
3. Temporal Issues
   
1. Historic
2. Recent
3. Current
4. Vegetative Signs

6. Psychological Effects

1. Behavior
2. Thoughts
3. Emotions
4. Feelings

7. Experiences

1. Family Effects
2. Behavior
3. Social
4. Family
5. Friends

8. Psychological Issues

1. Stress Level
2. Locus of Control
3. Attribution
4. Coping Methods

9. Interference

1. Personal
2. Social
3. Household
4. Out of the House
5. Physical

10. Change

1. Ability to physically Relax
2. Coping with pain
3. Relationships with others
4. Strength and Endurance

11. Coping Methods

1. Type
   
1. External Focus
2. Substance Focus
3. Internal Focus
2. Effectiveness

Development Background

We reviewed and studied the literature and consulted with additional experts in the fields of medicine, psychology, sociology, management, behavioral medicine, and psychometry. This phase also included a review of thirty years of research and treatment effect including a comprehensive review of articles and their references, books and their references. We also utilized computer searches of the associations in the field including Medline, psychological abstracts, and sociology abstracts for the past thirty years.

The development of the instruments involved a comprehensive development process and scientifically sound selection criterion. The development process included:

 We reviewed every available instrument reportedly used in medical, psychological, and quality of life assessments and measurements on an international, national, and local basis. We built a comprehensive database of thousands of appropriate items based upon the assessment and treatment literature, consultation, and thirty years of clinical practice.

We then made a careful review of the available items for content validity and classification. We then refined the item database to select the most relevant items for the medical review and the treatment measures

The selection of items was based on pre-established criterion. The measures included a comprehensive analysis of the items:

We continued the content specifications and item writing by a careful item analysis. The item analysis included an assessment of item content, difficulty, validity, and item discrimination. We then conducted a cross validation analyses.

Validity Background

Any data collection instrument should have an established validly and reliability. Our instruments are psychometrically sound.

The instrument was pre-tested on a select group of subjects who were administered these measures and standardized instruments in the field. The process included the following:

 The content validity was established. The purpose was to establish how well the content of the test actually samples the desired material so that valid conclusions can be drawn.

The criterion-related validity was established. Test scores were compared to one or more external variables considered to provide a direct measure of the behaviors in question.

Construct validity was established. The purpose is to establish the degree to which explanatory concepts and constructs account for performance on the measure. Careful attention is being taken to insure objectivity of the items and scoring, sampling, and temporal influences. The process included the following:

 The reliability of the instruments was established. The task was to show the accuracy, consistency, and stability of the measure. Reliability can be measured by testing and re-testing subjects, conducting a split–half correlation, and/or administering alternate forms. We measured reliability by:

Scaling Validity

The instruments have statically established scores and scales. Data reports provide a range of important information. The data reports include the following:

Scaling focused on

Analysis included

Benefits

The instruments provides a state of the art structured interview system for non-specialist and non-mental health specialists to use in research settings where valid and reliable assessment, diagnosis, monitoring, inclusion, and exclusion are a premium.

The application of current assessment and research tools requires considerable experience in diagnosing the condition in order to apply appropriately the tools.

Persistent inter-rater reliability and compliance problems in large and multi-site studies can be controlled.

The instruments document what is actually done.

The interviews

Assist in the standardization and compliance of inclusion and exclusion criteria.

Provide a structured approach to systematic data collection and management, based on reliable and valid work in the field.

Provide oversight staff [i.e., Management, Medical Director, Clinical Research Associates and Statisticians] with the ability to have feedback on multiple clinical research organization's compliance to the research protocols and essential data.

The interviews

Help to systematically collect, monitor, and report data on essential study factors.

Monitor and report on termination issues, early termination, and / or withdrawal.

Provide for in depth information and analysis of important issues.

Provide measures for clinical study data collection and scoring.