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Matching Treatment to Patient Needs in Opioid Substitution Therapy
Treatment Improvement Protocol (TIP) Series 20

Chapter 5 -- Self-Monitoring and Evaluation

Self-monitoring and evaluation are ways of gaining dynamic, reliable, and up-to-date information about patient and program characteristics and the frequency and efficacy of services delivered. This information is necessary to accurately describe patient flow and service delivery patterns and to examine outcomes. Self-monitoring and evaluation need not be complicated or excessively time consuming. They do not require extensive resources.

This chapter is directed not to evaluators and researchers but to personnel working in the alcohol and other drug (AOD) treatment field who are interested in applying evaluative tools to their work and moving their programs toward increased self-monitoring and evaluation.

In the following pages, the concepts underlying effective self-monitoring and evaluation are explained. A step-by-step guide to evaluation is provided, which explains how and why each step should be followed. Examples make it clear how these processes are pertinent to this Treatment Improvement Protocol (TIP) subject -- matching patients to type and intensity of opioid substitution therapy services. Instruments are suggested, and a detailed hypothetical example is presented within the framework that has been outlined. The example demonstrates not only how an agency can monitor itself on one specific issue (the effectiveness of treating methadone patients with a high level of psychopathology is the example used), but also how it can use the information gained from this study to make changes in its program, and how the effect of those changes can then be evaluated.

A very basic introduction to the concepts of monitoring and evaluation is outlined here. To understand the distinctions among these various concepts, it is helpful to look at a continuum of evaluative efforts and what their aims are. Those wishing a more advanced approach are directed to other sources, and to another TIP, entitled Developing State Outcomes Monitoring Systems for Alcohol and Other Drug Abuse Treatment. It provides more detailed discussions of the principles and goals of outcomes monitoring and their importance in the current healthcare environment. The National Institute of Drug Abuse (NIDA) has developed a valuable package, entitled How Good Is Your Drug Abuse Treatment Program? (National Institute on Drug Abuse, 1993), which provides practical guidelines.

Other useful sources include a number of publications that report the outcomes or results of research studies on AOD abuse treatment (Ball and Ross, 1991; Hubbard et al, 1989; Pickens et al, 1991; Rounsaville et al, 1993; Simpson and Sells, 1982; and Tims and Ludford, 1984). Full reference citations are provided in the Bibliography, Appendix A.

Self-Monitoring

Self-monitoring, the first point on the continuum, is something a program does to help itself. It is generally perceived as more modest in goals and execution than self-evaluation or evaluation done by an external source. Self-monitoring usually refers to the selection and regular inspection of intermediate indicators of patient outcomes (which, it is hoped, are predictive of final outcomes).

Self-monitoring employs tools that are nontechnical and easy to use. It utilizes a program's internal resources to collect and analyze information in a focused area. It incorporates some kind of feedback system. Optimally, self-monitoring is a continuous part of a program's operation, with periodic assessment of results and action taken in response to findings.

Program Evaluation

Program evaluation is a more elaborate form of monitoring than self-monitoring, using a more formal methodology. It may be done by internal or external evaluators. Its objective is also quality improvement.

Evaluation can be done by the State, by a reimburser, by an independent evaluator, or by a program itself. Evaluation does not have to be an overly ambitious, expensive, or daunting prospect. It need not be elaborate. It does not have to include all the elements of an academic research evaluation project, which tests a hypothesis. Rather, it can be a specific, focused effort to determine whether a program, or part of a program, is meeting specific goals and objectives.

Evaluation can begin with the basic formulation of a few questions and can then look for ways to answer them. It can cover a broad range of activities, but persons wanting to evaluate their program need not be overwhelmed by looking at the full range. A program can keep it simple, beginning with a small component to evaluate, then selecting and choosing the questions that -- when answered -- will provide the most useful information. Any well-conceived effort, no matter how limited, can contribute to better understanding of treatment practices.


Evaluation need not be elaborate. It can be a specific, focused effort to determine whether a program, or part of a program, is meeting specific goals and objectives.

Why Evaluate?

Evaluation is an important and necessary part of the operation of any opioid substitution therapy program. It gathers information that is useful and based on measurable data collected by the scientific method, rather than on intuition and impression.

Self-monitoring and evaluation serve to meet patients' needs. Both approaches study active elements of treatment. By measuring treatment progress and outcomes, self-monitoring and evaluation can improve the process of patient matching. They can help identify populations that need specific services and can evaluate the effectiveness of such services once they are implemented. They can support program and policy changes and can document the effects of changes on policies and procedures. They can help with decisions about cost-effectiveness and suggest new ways of looking at programs. The application of these uses will be illustrated in the hypothetical example at the end of this chapter.

Regulatory requirements, and questions that arise from them, can serve as triggers to suggest specific self-monitoring and evaluation needs. In this era of managed care and limited funding, it is increasingly important to implement a program of self-monitoring and evaluation. Such a program should be part of an organization's quality improvement strategy and its accountability to regulators and to the public. Some external agencies, including reimbursers, seek the demonstration of effectiveness that evaluation can provide. Evaluation can help programs satisfy regulatory requirements and document compliance with regulations and standards.

Evaluation can be useful at any point in programming, certainly not only at patient discharge. This point is particularly pertinent to the long-term, continuing nature of much of methadone treatment. Periodic behavioral change, not just final outcomes, can be measured by evaluation.

Most studies collect baseline data and then establish an endpoint that is either the point of discharge or a point at a specified time after the beginning of treatment. Such approaches may provide some useful data. However, in a program where patients may not be discharged or may not complete treatment for a long time, it is also necessary to look at continual measures of change. This view may mean revising standard notions of outcomes evaluation, because there are no outcomes to study other than behavioral change within treatment. It is important to note that outcome does not necessarily imply finality, even when the patient leaves treatment.

The results of evaluation can feed directly back into treatment services. For example, once information has been gathered about baseline rates of drug use, staff and patients can set goals -- such as the goal of reducing positive urine tests to a certain level. As data are collected, they can be used to revise goals as necessary. The goals of evaluation vary greatly among programs. In setting treatment goals, tradeoffs have to be made between the intensity of service and the number of patients who can be served. The ideal situation is to provide services for all those who need them in as intensive an approach as necessary. However, achieving this goal is usually impossible in practice.

Evaluation also serves an important public education function. Despite the large body of literature demonstrating the efficacy of opioid substitution therapy, there remains much public skepticism about whether it works. Sometimes this skepticism is related to philosophical differences. For example, many people feel that addiction should be treated only in a drug-free environment. Skepticism may also be more experiential. Citizens reading in their local newspaper about drug trafficking in the proximity of a methadone clinic may jump to the unjustified conclusion that the program is not effective in treating opioid addiction. Thus, negative opinions are formed.

To the extent that self-monitoring and evaluation can demonstrate that opioid substitution therapy achieves its goals with a certain number of patients, they can perform a valuable role in public education. If a study showed, for example, that of the 200 people served by a methadone program more than 75 percent tested negative for illicit drug use a year after entering the program, the study would be a useful demonstration of program effectiveness that could be brought to the attention of local public officials and the media. Evaluations can be designed specifically to gather information to present to public officials, legislators, or State agencies to illustrate specific points.


To the extent that self-monitoring and evaluation can demonstrate that opioid substitution therapy achieves its goals with a certain number of patients, they can perform a valuable role in public education.

Goals of Evaluation

A primary goal of evaluation in the context of this TIP is to improve the process of matching patients to opioid substitution therapy services. In many programs, decisions about matching are often made intuitively. Evaluation can help to assess the impact of these decisions. It can provide both prospective and retrospective data to quantify the matching process and can identify patients needing additional or different services. Evaluation of the matching process can be valuable in the following areas:

  • Phases of treatment
  • Levels of care
  • Types of services
  • Identification of specific program elements
  • Identification of subpopulations.

The public expects certain results from drug treatment in general, and methadone treatment specifically, including the cessation or reduction of illegal drug use, the reduction of crime, and improvement in patients' social functioning. Programs may also want to assess patient progress in treatment. Evaluation is one way to determine if public expectations are being met and how patients are progressing in treatment. In some cases expectations may be unrealistic, for example, that patients will stop all drug use, become abstinent after a certain period, or remain abstinent once they leave treatment. Evaluation results can provide a realistic picture of what can be expected from methadone treatment, as well as demonstrate the extent to which patients are meeting these expectations.

Although the task of establishing evaluation goals may sound straightforward in the context of opioid substitution therapy programs, it can be quite complex. Patient characteristics, program philosophy, and State licensing and reimbursement requirements can influence this process. For example, the duration of treatment may be prescribed by State policy. In some States, a course of methadone treatment is limited to 2 years; others support much longer-term therapy that may continue for a dozen years or more. A program that has time-limited treatment and patient goals directed toward becoming medication free (methadone free) presents different issues than a program whose goals focus on achieving a change in lifestyle with the continued use of methadone (or another opioid substitute). Therefore, the goal of evaluation must be considered within the context of the goal of the opioid substitution program.

Evaluations can be used as mechanisms to influence policy change. Data collected can provide information for reimbursers, who may be inclined to limit treatment, contain costs, and make services available to more people. When establishing objectives and designing self-monitoring and evaluation projects, it is critical that these distinctions be understood and considered and that the goals be clearly established. This issue is discussed in greater detail in the section of this chapter on the role of program philosophy in evaluation.

To determine clear objectives, questions that should be asked include

  • Is the program working as well as it should?
  • How can it be improved?
  • How does it compare with similar programs?
  • Are patients being matched to appropriate treatments?
  • How satisfied are patients with the services provided?
  • What happens when changes are made?
  • Can the program be more efficient and more cost-effective?

The Role of Program Philosophy in Evaluation

One of the sources of the variability discussed above is program philosophy. Program personnel sometimes do not use known results of research and evaluation to guide clinical practice because these results support the use of techniques that differ from those consistent with their own particular program philosophies. Very strong feelings and emotions are often involved, and the role of the evaluator is to remain neutral. The effect of program philosophy is one aspect that should be evaluated and considered.

Issues of program philosophy that must be considered include the following:

Short-term vs. long-term treatment. As discussed above, the length of treatment relates to the program's ultimate goal. Is the ultimate goal abstinence from any drug (including methadone), or is it a significant reduction of drug use within a long-term maintenance model?

Specific goals centered on HIV and AIDS. These goals can involve a number of areas -- perhaps most critically, the program's discharge policies. For example, since human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) is such an important factor in treating injection drug users, should patients be kept in treatment as long as possible with the expectation that this length of stay will reduce HIV transmission? This question has an increasingly important impact on evaluation, as well as on treatment decisions and the establishment of program goals. HIV has tipped the balance of the argument about the duration of methadone treatment toward liberal retention policies. This factor has come to play an increasingly important role in program evaluation, particularly in jurisdictions with a high incidence of HIV infection.

Dosage levels. Dosage levels, which are discussed in greater detail in Chapter 4, are frequently a matter of dispute and controversy. Determination of dosages may be based as much on philosophy as on clinical guidelines. This additional philosophical issue must be considered within the context of evaluation.

Various other program policies and practices may be influenced by philosophy. In different models, the same data can be interpreted in radically different ways. For example, consider a study comparing illicit drug use in a program based on an abstinence model and in a substantial-reduction, long-term maintenance-model program. In the abstinence program model-program, the finding that sporadic use occurs in 50 percent of the patients after 2 years of treatment could be interpreted by some to represent a substantial failure. However, in the long-term maintenance-model program, the reduction of drug use from 100 percent to sporadic use in 50 percent of the patients, with the other 50 percent being abstinent, would represent a major gain.

Outcomes and Process Evaluation

The evaluation of outcomes and of process are different, requiring different approaches. Both approaches should be considered since they answer different questions. Outcomes evaluation focuses on results; process evaluation focuses on how results were achieved and tends to identify the active ingredients of treatment. A subset of process evaluation is implementation analysis, which evaluates the success of an action that has been taken in response to the results of an evaluation.


Evaluations can be used as mechanisms to influence policy change. Data collected can provide information for reimbursers, who may be inclined to limit treatment, contain costs, and make services available to more people.

Outcomes Evaluation

Outcomes evaluation focuses on the patient and patient progress (or lack of progress) during and after participation in a program or some facet of a program. When looking at outcomes evaluation, terms such as "success" and "failure" should be avoided; rather, considerations of progress markers and behavioral improvements should be the guideposts. Even small improvements may be significant, and feedback can provide important reinforcement to the staff and encouragement to the patient. For example, a patient outcomes evaluation might measure drug use (as quantified by the results of urinalysis) in patients with high levels of psychopathology who are referred for mental health services. This example is discussed in detail at the end of this chapter.

Researchers measure a variety of variables to assess outcomes of treatment for opioid-addicted patients. These may include drug use, criminal activity, attitudes, vocational skills, employment, institutional adjustment, family relationships, and involvement in social activities. The particular measures chosen should include the behaviors specified in the goals and objectives of the programs. The evaluation of a treatment program designed to reduce substance use, decrease criminal involvement, improve self-concept, and increase job skills must collect data in each of these areas to determine whether the expected changes have taken place. Other areas can also be measured to assess the general impact of the program on patients' behaviors or on aspects of the larger community.

Outcomes evaluation can also measure and assess the impact of a program or an element of a program, and its ability to produce desired changes in the patients who are exposed to it. For example, a program might provide bus tokens to its patients to help them with transportation to and from services. After a certain period of time during which the bus tokens are provided, an evaluation might be conducted to determine whether program attendance has improved. This is an example of a simple evaluation for which only attendance data would need to be collected. The most reliable evaluation uses a control group for comparison (for example, a group of patients to whom bus tokens were not provided), but this is not always a practical approach for programs to take.


Researchers measure a variety of variables to assess outcomes of treatment for opiate-addicted patients. These may include drug use, criminal activity, attitudes, vocational skills, employment, institutional adjustment, family relationships, and involvement in social activities.

New programs provide an opportunity to build in continuous data collection mechanisms from the start. Programs may choose not to use the data, but evaluation should be built in. However, it is important not to begin evaluation too early when implementing a new program or part of a program. The program should become stabilized before evaluation begins.

Process evaluation. Process evaluation describes what is happening within the "black box" of the treatment program. "Black box," a commonly used term in this context, refers to the concept that patients go into a program as known and described entities and come out with certain measurable outcomes; but what actually goes on in the program -- or black box -- is not readily apparent. Process evaluation allows for successful replication of programs that are achieving their goals, because it looks at the factors that are responsible for this goal achievement.

By documenting what actually happens over the course of the intervention, a process evaluation can help interpret the results of outcomes evaluation. Also, either explicitly or implicitly, the results of a process evaluation provide an assessment of the strengths and weaknesses of a program and suggest ways in which the program can be improved, thereby serving as a management tool for program development. Finally, the documentation produced by a process evaluation can be used to develop a manual describing the theory and practice of the treatment program, a helpful guide for others wishing to replicate the program.

Process evaluation has proved to be a useful tool for examining the procedures of a treatment program in comparison with its stated intent. Through a process evaluation, the evaluator can determine whether the subjects actually received an intervention as it was intended to be delivered. The evaluator can also measure the intensity and duration of the services received by the subjects.

Implementation analysis is a particular type of process evaluation that can be applied to new programs or new program elements. Implementation analysis should begin as early as possible in order to fully document the process. It is also useful, once an evaluation has disclosed that over time, as a result of something new, certain changes have been taking place -- for example, increased attendance at counseling sessions since the provision of bus tokens. Implementation analysis describes how the new program was implemented, considering what the steps were and who the players were. The analysis looks at such things as planning meetings (when they were held and who attended), specific problems and barriers that were encountered, strategies that were used to overcome problems and barriers, and modifications to the original plan that were necessary.

What Can We Learn From Previous Studies?

The benefits and problems of methadone treatment have been studied extensively. Much can be learned from the evaluation work that has already been done in this field, including what the greatest needs are for future evaluative work. Data have been collected to describe effects of opioid substitution therapy on reductions in injection drug use, other drug use, criminal activity, unemployment, and other areas. Instruments have been designed to collect these data. A body of literature focuses on medication levels, treatment program variation, and factors that are predictive of retention. Some of these studies are discussed in Chapter 1 and in another TIP State Methadone Treatment Guidelines.

There are a number of good literature reviews of evaluations of methadone treatment (Ball and Ross, 1991; Cooper, 1992; Hubbard et al, 1989; Institute of Medicine, 1990b; Simpson and Sells, 1982; Simpson and Sells, 1990; Tims et al., in press).

The existing literature can inform the process of evaluation and program improvement. It can offer evaluators a sense of what is generally acceptable and examples of how other programs typically define success rates. The results of earlier evaluations can suggest ideas about how existing work can be applied or adapted to particular program needs and how it can guide current evaluative efforts.

There are large gaps, however, in existing work. Only a few studies have been done of the actual process of matching patients to services. A 1990 report from the General Accounting Office (GAO) found that none of the methadone maintenance programs studied "systematically evaluated their effectiveness in treating patients." Virtually none of the studies have used control groups. Most studies have high dropout rates (Simpson and Joe, 1993). Results must be considered within the context of these limitations.


By documenting what happens over the course of the intervention, a process evaluation can help interpret the results of outcomes evaluation and can be used to develop a manual describing theory and practice of the treatment program.

Getting Ready to Evaluate

This section offers a general look at evaluation that can be related specifically to opioid substitution therapy programs and even more specifically to patient matching within these programs. The methodology that is used in individual studies depends on the purpose of the specific evaluation, but a number of general principles are applicable to any evaluation.

General Principles

Keep It Simple

The evaluation should not be overly ambitious. A poorly designed evaluation is likely to be worse than no evaluation at all. The best way of ensuring quality and achieving goals is to keep the project manageable. The less complex an evaluation project, the more likely it is to be well planned and implemented.

Use Evaluation as a Problem-Solving Tool

As discussed in the introduction to this chapter, evaluation can provide data for both internal and external use. Externally, data can be used to provide accountability. Internally, data can be a valuable agent for quality improvement. In the context of the philosophical problems that opioid substitution therapy programs may encounter and their need to explain their methods and goals, evaluation can help demonstrate program effectiveness.

Use Available Data Whenever Possible

Evaluation does not need to be a major undertaking that starts from scratch. Often data already available can be plugged in to answer the question being considered for evaluation. Use of available data is discussed in greater detail in the section of this chapter on the data collection process. One primary fact to remember in using previously collected data is that the data must be handled consistently and applied appropriately. In other words, apples shouldn't be compared with oranges.

Don't Work in Isolation

In designing and implementing self-monitoring and evaluation projects, it is desirable to include personnel involved in various aspects of programming whenever possible. Staff investment in and commitment to the study is critical for the success of the project. A number of different approaches can be considered.

One is creating a team. Team members can provide a range of expertise and opinions for the evaluation process, even if no members are actually specialists in evaluation. An evaluation team might include the members of the treatment team, including the program director, the medical director, counselors, nurses, and educators.

Another approach is to contract with an outside agency to perform the evaluation. Whether the evaluation is done internally or by an outside agency depends on several factors, including internal resources, available funding, and the purpose of the evaluation. If it is being done for internal information-gathering or quality improvement purposes, and program personnel are confident that the data collection procedure will provide reliable data, an in-house effort may be sufficient. However, independent (external) evaluations often have more credibility and may be necessary if an evaluation is being conducted, for example, to demonstrate effectiveness to payer sources, the State, or other regulators or interested parties.

Programs located in communities with universities can sometimes gain valuable help from faculty and doctoral students in designing and implementing research studies.

Domains

Ball and Ross (1991) describe four domains that must be considered in evaluating substance abuse treatment. By considering each of these four areas for data collection and study, the treatment process can be broadly conceptualized and insight can be gained into what actually occurs in treatment. Evaluation strategies may differ for each area, and these should be considered in a general way before designing an individual evaluation project. A common pitfall in designing evaluation studies is looking at only one domain. Once a broad overview is achieved, programs can select the variables that are most meaningful for their study, assigning primary or secondary values to them. Each domain is discussed briefly below.

Patients. Information gained from life histories and current health surveys of opioid-addicted patients has long been valued as a tool for treatment evaluation. Collection of these data has always been emphasized in substance abuse treatment, although the focus of treatment has changed somewhat through the years as addicted patients have been considered increasingly within medical and psychiatric contexts.

Programs. Ball and Ross (1991) describe the domain of the treatment program as "conspicuously neglected" in most substance abuse treatment evaluations. They list four program areas that should be considered:

  • Setting or environment
  • Policy
  • Staff and leadership
  • Physical facility and other resources.

Services. In looking at the actual provision of treatment and adjunct services, evaluators should consider

  • Methadone dosage
  • Clinic hours
  • Number and type of counseling sessions
  • Medical and psychiatric services
  • Educational and vocational services
  • Urine screening
  • Any other services that are provided.

Outcomes. Common outcome criteria that have been studied include measures of drug use, criminality, treatment retention rates, and employment status. The study of outcomes is discussed further in the next section of this chapter.


Four general principles should be used in designing evaluations:
  • Keep it simple.
  • Use evaluation as a problem-solving tool.
  • Use available data whenever possible.
  • Don't work in isolation.

Steps in Conducting an Evaluation

By answering the following eight questions in order, a step-by-step approach to evaluation will proceed in a logical, systematic fashion:

  • What do you want to know?
  • What data are needed to answer the question?
  • What information is already available?
  • Who or what will be studied?
  • How will you collect the data?
  • What are the results?
  • What do the results mean?
  • What is next?

What Do You Want To Know?

Determining exactly what you want to find out from your evaluation involves a number of steps in order to refine and focus the evaluation questions as much as possible:

  • Arrive at a broad goal statement. Why do you want to know the answers to the questions you have posed? What is the goal of obtaining this information?
  • Move from articulating the general goal statement to defining specific objectives. A general goal might be to improve patient outcomes. This goal must be narrowed to a specific, feasible project that can be measured through evaluation.
  • Identify the question as either a process or outcome question. Examples of outcome questions are, "Will providing childcare reduce program dropouts among parenting women?" or "How effective is the program in treating patients with high levels of psychopathology, and how often are these patients referred for mental health services?" An example of a process question is, "What are the problems and barriers in providing mental health services for patients with a high level of psychopathology, and what strategies can be used to overcome these problems?"
  • Look at what others have learned about this question through previous research. The National Clearinghouse for Alcohol and Drug Information (NCADI) is a useful resource for this purpose.

Determine the relevance of previous research to your specific evaluation project. What you find in existing research may help further define your evaluation questions and identify instruments that may be used to collect data.

As previously described, questions about methadone therapy have been answered in a number of studies through the years. For example, it is well documented that the longer patients stay in treatment, the better they do; likewise, the more services they receive, the better patient outcomes will be. Instead of attempting to look at these broad questions that have already been answered, most evaluators would do well to focus their studies more narrowly and look, for example, at questions such as

  • How can patients be retained in the program for the first 90 days (the period critical to their becoming engaged in treatment)?
  • What are the reasons given for dropping out of treatment?
  • What is the range of services that patients receive?
  • How does the program use the results of urine screens?

What Data Are Needed To Answer the Question?

Some factors that will help determine what data are needed include whether the evaluation being done is a process or outcomes evaluation, which domains are being covered, and whether an implementation analysis is involved.

Define the Categories of Data

The data that are collected should be directly relevant to the question and should consider all domains appropriate to the question. When considering how well patient matching procedures work, the approach should consider both program and patient variables. As Ball and Ross (1991) have pointed out, there is often a tendency to look only at patient data when evaluating. But it is important to consider the other areas that are appropriate to the question, such as program setting, services, staffing, and so forth.

Select Specific Variables

The specific variables about which data will be collected will depend on the question. Variables may be quite diverse and may include patient, program, and outcome variables. For example, patient variables may include gender and ethnicity; program variables may include staffing ratio, number of scheduled counseling appointments, and dosage levels; and outcome variables may include rates of positive urine tests, patient satisfaction, and compliance with scheduled counseling appointments.

A word of caution about variables: If the number of variables under consideration for a planned evaluation seems to be approaching an unmanageable level, it is likely that the project is overly ambitious. This is a clue to reconsider and reduce the scope of the original question.

What Information Is Already Available?

Next, it must be specifically determined what data are already available that pertain to the selected variables. What relevant information is already in program records? What existing data are available elsewhere, where and in what form, and how can these data be abstracted? What, if any, are the barriers to obtaining it? Are there confidentiality issues that affect extracting and collecting data? Are existing data in a form that can be used for comparative purposes with the data that will be obtained from this evaluation? One possible starting point may be to establish a uniform data set, if this does not already exist. A program may standardize assessment forms or instruments as well as indicators of ongoing progress.

When possible, data to be used in evaluations should be computerized. Computerization creates a database that can be used in subsequent projects, and provides a format for quantifying information for the current project.

Existing resources may include

  • Program data (for example, patient records, results of urine testing, and administrative and fiscal information)
  • The National Drug and Alcohol Treatment Unit Survey (NDATUS)
  • Client data system
  • State uniform data sets (if available)
  • Community social indicators
  • Census data
  • Health indicators
  • Crime data.


Patient variables may include gender and ethnicity; program variables may include staffing ratio, number of scheduled counseling appointments, and dosage levels; and outcome variables may include rates of positive urine tests, patient satisfaction, and compliance with scheduled counseling appointments.

Who or What Will Be Studied?

The next step is to identify the population or process that is to be evaluated. This identification depends on the evaluation question. For example, does the evaluation concern new patients coming into a program and how they will be matched to treatment? Or is it a look at outreach to a critical population such as addicted persons who are human immunodeficiency virus (HIV) positive, pregnant women, polydrug abusers, or people with disabilities? Or is it limited to assessing how existing patients are being matched to new or different services?

It may be a "what" rather than a "who" that is being evaluated. In the case of a State evaluation, the "whats" may be programs or elements of programs -- for example, program procedures such as intake or patient matching; program elements such as specific interventions, staff ratios, and characteristics; administrative procedures such as payer mix or dollar costs; or patient movement through phases of treatment.

After these determinations have been made, it is then possible to decide on the sampling strategy. Factors influencing this strategy include the scope of the research question, the resources, and the size of a program. A study of a small program may include everyone in a program. In other evaluations, for a number of reasons such as resources and manageability of the data, it may be necessary to sample only a portion of the population to be studied. If an evaluation is being conducted at the program level, the best procedure may be to sample among programs.

Sampling strategies also depend on the problem to be studied. For example, in a study focused on the program's success in administering purified protein derivative (PPD) skin tests for tuberculosis (TB) or on completing a physical examination on admissions, every patient admitted over a specified period of time might be sampled. On the other hand, if the study is focused on evaluating the frequency of opioid- or cocaine-positive urines, a random sample of persons who have been in the program for less than 6 months might be compared with a random sample of those who have been in the program for more than 2 years. Or, the rate of positive urines in the sample of newer patients could be compared with the overall rate of positive urines in the entire clinic.

It should be determined whether the evaluation will require approval by an institutional review board concerned with protection of human subjects and if patient consent is necessary. Care must be taken to ensure that consent is truly informed; the fact that patients are dependent on the opioid substitution services might give program staff undue influence over patients. This influence should not be abused in the evaluative process. Also, confidentiality must be ensured whether data are stored in a computer or in a paper file. Any other relevant ethical issues must also be considered.


It should be determined whether the evaluation will require approval by an institutional review board concerned with protection of human subjects.

How Do You Collect Data?

Selecting or Designing an Instrument

Data must be collected in an empirical, quantitative form. The first step in data collection is the identification or development of an instrument to be used for this purpose. The program may already collect data in a form that is amenable to the evaluation project, such as the results of urine tests or attendance records.

The development of a data collection instrument involves several steps. It is necessary to devise data fields, draw up a draft of the instrument, pilot test it, and then revise it based on results of the pilot study. Although this sounds complex -- and is, in some cases -- it can also be quite simple. The instrument may be just a single sheet with a few boxes on it. Piloting the instrument may simply involve a counselor's asking questions of a few patients. This procedure does not need to be a daunting, complicated process.

Certain guidelines must be followed so that the information collected is congruent with other existing resources. This is part of the challenge of putting together an instrument, and one of the reasons that all but the most experienced evaluators should probably use (or adapt) existing instruments. For example, if the instrument is to include an ethnicity category, it is necessary to be aware of the various ways to categorize ethnicity. Another example is drug use categories. An instrument may use the term narcotic to refer to opioids; another may use legal definitions and include cocaine or even marijuana under the narcotic category. Some consider alcohol a sedative-hypnotic drug, and others consider alcohol in a separate category. If questions are developed, categories should be parallel to those used in other data sources, so that collected data will be comparable with the other data.

A program developing a complex data-collection instrument should use the services of evaluation experts and consultants whenever possible. Many existing instruments may be applicable. For example, the Addiction Severity Index (ASI) or sections of the ASI may be useful. Several existing personality inventories may also be useful. Serious consideration should be given to using existing instruments, or portions of them, if they are appropriate. Sometimes only a few modifications are necessary to adapt an instrument to a program's particular evaluative purpose. Adapting an instrument is usually much easier than trying to invent a new tool.

A wide variety of such instruments is available. NIDA publishes a comprehensive list of existing instruments in the Diagnostic Source Book on Drug Abuse Research and Treatment (Rounsaville et al., 1993). Another useful guide is the DATAR Forms Manual: Instruments Used for Data Collection (Simpson, 1992). DATAR is the Drug Abuse Treatment for AIDS-Risk Reduction project, which included an extensive evaluation component. The project is reviewed in a recent article by Simpson and associates (Simpson et al., 1995).


Serious consideration should be given to using existing instruments, or portions of them, if they are appropriate. Adapting an instrument is usually much easier than trying to invent a new tool.

Frequency and Duration of Data Collection

Part of designing an evaluation includes deciding with what frequency and over what duration of time data will be collected. If data are to be collected more than once, it is possible that more than one instrument will be necessary. These questions relate to whether the evaluation is a one-time look, or a survey of changes over time. If it is a one-time look, these questions are not applicable.

Staff Training

Training staff members to perform self-monitoring and evaluation does not have to be extensive or complicated. However, for data to be useful, a certain amount of training and staff support is necessary to standardize procedures and assure quality. Data must be collected using standardized methods in a way that protects its integrity. A written protocol explaining exactly how data should be collected is usually the best way for staff to understand the procedures to be used. Although all staff must participate, it is often best to assign responsibility for collecting data to one or two staff members.

Another purpose of training is to address concerns of staff members about the use of the results of the evaluation. There are no "right" or "wrong" results of evaluation. However, program personnel know that certain findings may reflect poorly on a program and may even jeopardize funding or accreditation. Staff members must be taught to use results -- whatever they may be -- in a proactive way, bringing problems out into the open and addressing them. Evaluation presents an opportunity for a program to move in a positive direction, perhaps seeking outside help from State technical assistance services. Programs that incorporate self-monitoring and evaluation information into a plan for improvement will be looked upon positively by the State, by regulators, and by reimbursers.

It is also important that procedures be developed to address specific points when conducting an evaluation. Interviewing is one area that often must be addressed. When interviewing patients is part of the evaluation process, procedures for interviewing should be prescribed. To some extent, the structure of the interview will be determined by the instrument used. Data collected in the interview should be quantifiable, and staff should receive training in conducting the interview in a way that will elicit data that can be quantified.

The interview site is another important consideration. The decision of whether to conduct interviews in a waiting room or in a private office, for example, could influence the way that patients respond to questions. Another issue to consider is how to record or account for patients who refuse to be interviewed. Also, if the work involves abstracting information from existing patient records, it must be determined when this work can best be done so that records are still available for staff to use for routine purposes.

When all the data are gathered, standardized procedures are used to code, to enter, and to store data. These procedures require staff training and monitoring to ensure consistency and quality. Ever-increasingly, this type of work is being performed on computers, and the use of a computer is necessary for a large or complex project. However, it is important to note that computers are not essential for small-scale self-monitoring and evaluation. For some evaluations, a simple checklist is all that is necessary. If you are doing a study of drop-out rates, for example, your data may consist of simple, hand-drawn line graphs.


Computers are not essential for small-scale self-monitoring and evaluation. For some evaluations, a simple checklist is all that is necessary.

What Are the Results?

The results are to be found in the data that have been collected through the evaluation project. If data have been accurately defined and collected, they should provide at least some answers to the questions originally posed.

For example, suppose a program wants 100 percent compliance with PPD skin testing for TB. Investigators review 20 consecutive intakes over a 2-month period and find that five persons did not receive a PPD skin test. Corrective action is taken, and the study is repeated in 3 months. Consider another example: The program wants to be certain that all patients with more than one opioid-positive urine test a month are receiving adequate methadone doses. Records are reviewed, and all patients who have been in the program for more than 6 months and who have had more than one opioid-positive urine a month are identified. The treatment plan of any patient in this group whose methadone dose is below 60 mg is reviewed by a physician, the counselor, and the treatment team, and appropriate adjustments are made.

A data analysis strategy determines how the data should be aggregated and presented. Generally, results are compiled in an understandable format, which can vary from a simple percentage, bar, or line graph to sophisticated presentations. Usually some kind of narrative summary accompanies the graphic display of the results. Means or percentages must also be generated to make the statistics meaningful.

What Do the Results Mean?

The process of understanding evaluation results should involve consultation with experts and discussion among program staff. Objectives that were described in designing the evaluation and the interpretation of the statistical data are both factors in determining what the collected data mean and how the data will be used.

The first point to be determined is whether the results answer the question that the evaluation attempted to address. Results may be clear, but just as often they may not be. Even in well-designed and well-executed evaluations, results may be inconclusive, which should not be discouraging to evaluators. Such results may lead to additional questions.

The program may want to involve a staff member or outside consultant with experience in statistical interpretation to help with interpreting the results, particularly when they are not clearcut. The sensitivity, background, and experience of the evaluators who have collected the data and who prepare the presentation of the material will affect the interpretation and understanding of the results of an evaluation. Analysis can be a complex process. Even if results are clear, implications may be less apparent. Questions of statistical and clinical significance must be considered. Such considerations can be guided, in part, by comparisons to previous studies that have been conducted on the same or similar topics.

Again, most caveats about interpretation and implications apply primarily to the more difficult and ambitious evaluation projects. Evaluators should not be intimidated by possibilities that may seem daunting. Often results are clear and implications are obvious. For example, consider the hypothetical illustration of distributing free bus tokens in an attempt to decrease patient dropout rates in the acute phase of treatment. Baseline data show that before bus tokens were distributed, the dropout rate for patients in the first 2 months of treatment was 30 percent. After 3 months of tokens distribution, the dropout rate for patients in the first 2 months of treatment was 15 percent. The distribution of the bus tokens was the only change in the program. Without a control group, interpretation of findings cannot be absolute. But it is fairly obvious that the results of using bus tokens were encouraging, and it is a practice that the program would want to continue, if feasible.

If the dropout rate had gone from 30 percent to 25 percent, the results would have been less clear, and more subjective judgments would have been necessary about the value of the intervention. Sometimes other factors must also be considered. For example, suppose that the first 2-month period (before bus tokens were distributed) was an exceptionally rainy period, while the sun shone nearly every day after the token distribution began. It is possible that the weather may have had as much influence on program attendance as the distribution of bus tokens. Or suppose that another factor had been introduced in the same time period, such as child care for patients with young children. These are elements that must be weighed by evaluators and then factored into interpretation of the study. As well, decisions must be made about any action taken as a result of the study and the design of future evaluations.

The implications of a more complex study are explored in the section of this chapter outlining a hypothetical evaluation of the need for mental health services for methadone patients with a high level of psychopathology.


Even in well-designed and well-executed evaluations, results may be inconclusive, which should not be discouraging to evaluators. Such results may lead to additional questions.

What Is Next?

The final questions of the evaluative process are: How can the data be applied? How can the program be improved on the basis of this evaluation? Once it has been decided that evaluation results are valid, the results of evaluation provide program personnel with a foundation for taking their next step.

Programs are constantly making changes, and the purpose of self-monitoring and evaluation is to make these changes part of a more conscious and reflective process. When a change is contemplated, consideration should be given to what the result will be if that change is made. This is a basic purpose of evaluation -- make a change, look at what happens when the change is made, decide whether the results are sufficiently successful to continue, and, if so, institutionalize the change.

Perhaps the most important point is that evaluation results should not just be filed away but should be used in some manner. Some results will point to recommendations for change. In some cases, positive results can be used to publicize the accomplishments of a program. Other findings will indicate the need for further evaluation. Some evaluation results can serve as a basis for discussions with funders or can provide the foundation for funding applications.

Clearly, there are many different options to consider when deciding what steps should follow evaluation and self-monitoring and what kinds of changes should be made. A general rule is to begin with the least invasive intervention, which might be as simple as releasing the data. Other options might include establishing new policies, changing regulations, applying sanctions, or implementing certain educational requirements for staff.

Several examples illustrate the "What is next?" step. Suppose a program wants to find out whether there is a correlation between the amount of group counseling a patient receives and whether the patient stays in treatment. Once the data are gathered and analyzed, it becomes clear that increased numbers of group counseling sessions are correlated with retention in treatment. That information can provide the foundation for an education program to inform program directors of the findings and encourage programs to increase their group counseling sessions. From there, an implementation analysis (a form of process evaluation) can be conducted to determine if this intervention is actually having an impact on the amount of group counseling that is available in the various programs.

This hypothetical evaluation of counseling is an example of an evaluation in which the unit of analysis is the program, not the patient (in contrast to the bus tokens example). In studying programs, it is important to be aware of variables that may influence outcomes, such as the size and age of the program, staffing patterns, or other internal components.

Another example of how evaluation data might be used to move programs in a certain direction can be seen in the case of a study in a midwestern State that showed that when methadone dosages were above certain levels, rates of illicit drug use by patients were lower (as measured by urine screens) than were rates when lower methadone dosages were used. Knowing that average dosing levels were considerably lower than the cut-off rate in the study, State officials began a campaign to educate providers and policymakers that lower rates of illicit drug use were associated with higher methadone dosing levels. This campaign included distribution of articles explaining the study, as well as presentation of conferences and workshops for practitioners to further disseminate the information.

A Hypothetical Evaluation

A number of hypothetical examples have been referred to throughout the preceding discussion of self-monitoring and evaluation. The following example1 is a more complex exercise. Exhibit 5-1 shows the practical application of the eight steps of evaluation to a specific example of an inhouse evaluative project. Based on the results of the program then instituted, certain program changes are implemented for a period of time, and the effectiveness of the intervention is then evaluated, as shown in Exhibit 5-2.

Based on the results of the first evaluation, this hypothetical program then instituted the following actions:

  • Routine screening of all patients on admission and every 6 months, using the psychological status section of the ASI.
  • Establishment of formal liaison with a local mental health agency to ensure rapid intake for methadone patient referrals.
  • Assignment of case managers to monitor the followup to ensure that mental health assessment this and treatment actually occur.
  • Six months after initiating these changes, the program conducted a second study to evaluate the effectiveness of the intervention.

Conclusion

Self-monitoring and evaluation are important components of any opioid substitution therapy program. Whether a program employs self-monitoring for regular self-inspection or uses evaluation to solve a problem or to gain a better look at the effects of change within a program, provisions for monitoring and evaluation are a necessity to programs concerned about patient-treatment matching. Self-monitoring and evaluation allow a program to engage in continuous quality improvement.

Designing and implementing an evaluation component need not be extensive or complex. In fact, simple and manageable projects that address the interests of a specific program are generally more successful than projects that are overly ambitious. Evaluation can be used to identify service needs, assess the effectiveness of services, support program and policy changes, document the effects of procedural changes, assist in decisions about cost-effectiveness, and provide information for public education. Regardless of the program's area of interest, consider a systematic, step-by-step approach when designing the project. Include the four basic domains -- patients, programs, services, and outcomes -- to provide an overview of what actually goes in the treatment program. Use available data and existing instruments whenever possible. Work as a team; staff investment in and commitment to the study is a key for a successful project.

Endnote

1. The hypothetical example was created by Mark L. Willenbring, M.D.
 



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