Good practice management or research?

by Robert H. Blanks, PhD, Professor Emeritus, University of California Irvine

This is the fourth in a series of regular discussions on practice-based health outcomes.

Health outcomes assessment

Simply stated, outcomes data are important measures of the quality of health care because they are direct measures of whether health interventions have been successful.

There are dozens of companies offering a broad range of practice management software for: 1) enhanced revenue cycle, 2) improved cash flow, 3) collections, 4) practice growth, and 5) electronic office records.

Integrative Outcome Measures (IOM) is different in that it offers an on-line platform for conducting surveys (quality of life, health lifestyle behaviors) on patient-centered outcome measures. This is done to capture information on patient beliefs, values and health (wellness) behaviors while undergoing care in your office. Data reported by your patient are charted in comparison to a large normative database and their previous values for comparison to show progress with care.

Is this good practice management or research? IOM is a data collection network and does not conduct research. However, if a subscriber chooses to conduct research, they could use the IOM services to collect the data, and then initiate their own protocol approval for human subjects’ assurance from a local Institutional Review Board. The subscriber should consider the following:

In-office quality assurance

In-office quality assurance is not human subjects’ research. Examples include:

• Surveys for evaluation of health professionals and patients in a private setting or other studies where the data are for internal institutional use only.

• Secondary analysis of publically available data, such as reviewing US Census data.

How then is human subject research different?

As defined by the Department of Health and Human Services (DHHS 45.CFR 46.102 (d)), “Research” means a systematic investigation, including research development, testing and evaluation, designed to contribute to general knowledge. Simply stated, if you desire or may desire to publish the results of their project in a journal, or present some aspect of the project at an academic meeting, then you are conducting human subjects research and will need a protocol approved by an Institutional Review Board (IRB).

Federal regulations give the IRBs the authority to oversee research involving human subjects. All human subjects’ research requires review and approval by an IRB prior to subject recruitment and data collection, and prior to the use of patient data or private information. The IRB has no regulatory authority or jurisdiction to oversee activities that are legitimately classified as something other than research (see above).

When a project is designated “research”, as defined by the federal regulations, the next step is to determine whether the project involves “human subjects”. 45 CFR 46 (f): Human Subject means a living individual about whom an investigator conducting research obtains 1) data through intervention or interaction with the individual, or 2) identifiable private information. Intervention is defined as both physical procedures by which data are gathered (i.e. venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes. Interaction includes communication or interpersonal contact between an investigator and subject. Private Information must be individually identifiable (the identity of the subject is or may be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

IOM network security

The IOM surveys are validated statistically in published research and evaluate quality of life across multiple health domains including physical health, mental/emotional health, stress, life enjoyment and issues of patient satisfaction. The survey data are entirely anonymous and protected by multiple levels of security. They are expressly for the purpose of practice-based health outcomes in support of practice management. As such, good business practices require companies like IOM to provide: 1. authentication of users, 2. encryption, 3. password protection, 4. data back-up and 5. optional data destruction, if desired by the client, when the project is terminated. These safeguards protect the anonymity of the data and its security.

1. Authentication of users. Are the proper qualification and/or identification of the person completing the surveys on line? This issue is accomplished by assigning all participants a 24 character alphanumeric access code which they must supply to take the survey. The first 12 characters code the referring practitioner; the second 12 code the patient in that office. An e-mail address is submitted with the survey which allows a one-time return of the survey to the patient and reminders to take a survey when it is ordered by the referring office. However, the data are not stored with anything by the alphanumeric code and is therefore anonymous. The table linking patient identifiers with the alphanumeric code is known only to the IOM network managers, and to the referring practitioner.

2. Encryption. This is the first level of security. Patient data is transmitted in an encrypted or coded format using a Secure Socket Layer (SSL). This minimizes the risk that data intercepted during transmission could be decoded and traced back to an individual respondent.

3. Password protection. As a second level of security, all access to the IOM servers is password protected. One level of password is held by the administrators of the IOM database; a second level is known to the referring practitioner so they can access data from any member of their practice; and, a final level is known to the patient who can access data from their own survey only.

4. Data back-up. Data in the IOM servers is backed up every 12 hours. These files are stored in a safe location in a secure data room that is environmentally controlled and has limited access.

5. Data destruction if requested at the termination of the project. A competent data destruction service is used to ensure that no data can be recovered from old electronic media should the referring practitioner choose to delete all patient data at the termination of the study.

6. Patient populations and HIPAA privacy protection. The IOM surveys are only validated in adults. Therefore, a person must be 18 years of age or older to take the survey. The data collecting network at IOM complies with all guidelines of the Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA).

In performing in-office health outcomes assurance, one develops better ways to monitor and improve the quality of care and how one assesses the end results of health care services. The primary objective of these data is to promote and assess wellness behavior, pinpoint any major areas of concern, and otherwise stimulate structured feedback and discussion with the office and care and compliance with other aspects of the office wellness program.

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(Dr. Robert Blanks has served as professor in the Department of Biomedical Sciences at Florida Atlantic University and Professor of Anatomy and Neurobiology at the University of California, Irvine. He spent two years at the Max Planck Institute for Brain Research in Frankfurt, Germany and two years in the Department of Anatomy at Harvard Medical School. Dr. Blanks is on the Advisory Board of the International Spinal Health Institute, is a Board Member of the Council on Chiropractic Practice and is actively involved in chiropractic research.)