Lack of Outcome Studies for Treatment Efficacy

Lack of Outcome Studies for Treatment Efficacy

The profitability of the recovery industry is just one of the many dominos that have fallen in response to the opioid crisis. As The Notorious B.I.G. once articulated, with more money comes more problems, and the same has been the case in recovery.  

Now scams like body brokering and waiving deductions have made the transformative and holistic experience that is supposed to be addiction recovery into a potential system of insurance fraud, patient enticement, listing theft, and a host of many other schemes aimed at taking advantage of how profitable the field has become.

Lack of outcome studies for treatment efficacy is but another one of these scams that you or your loved one should be knowledgeable of. Instead of having legit studies done on how effective treatment is at their facility and how many people stay sober after leaving, some recovery centers make up numbers themselves or, at times, don’t even provide outcome studies. When treatment facilities don’t provide outcome studies, they lose out on clients and stray people away from seeking treatment at their facility.

Except, when they make up numbers themselves, it leaves clients susceptible to unethical treatment, as it takes them away from facilities that actually have great outcome numbers. Additionally, not enough controlled efficacy studies have been conducted to address the enormous public health problem that drug abuse has become.

Without research and funding support to help expand the small number of studies and the noted methodological limitations of these studies published to date, there will not be significant breakthroughs in drug abuse treatment.

Outcome studies are critical in the recovery industry. Practices that don’t provide accurate information on treatment outcomes are detrimental to both the client and the recovery industry. From defining outcome studies and clinical trials, including their shortcomings, to solutions and what you or your loved one can do to protect themselves, this is a one-stop-shop to understanding everything you need to know about the lack of outcome studies. It would be best if you were asking your treatment center their thoughts and, possibly, data that they have themselves.

I. Outcome Studies 

What Are Outcome Studies? 

In 1990, the National Institute on Drug Abuse (NIDA) initiated drug abuse treatment outcome studies (DATOS) to evaluate emerging treatment issues and drug abuse treatment outcomes.

The study was designed to advance scientific knowledge about the effectiveness of drug abuse treatment by determining whether or not outcomes of adult drug abuse treatment delivered in typical, stable, community-based programs are effective or not. When done right, DATOS can provide comprehensive information on either continuing or electing to ask new questions about the effectiveness of drug abuse treatment for adults. These studies are the result of a continued and unparalleled effort by NIDA to evaluate drug abuse treatment outcomes in each of the last three decades.

Ultimately, these studies were supposed to help shift public concern and expectations for treatment as well as provide leverage when talking about funding for new treatment centers and research on the neurobiological bases of addiction. Some of these studies even go as far as to evaluate the role certain types of programs have on treatment outcomes based on the client’s characteristics.

Behavioral factors such as dependence, treatment history, and physical and mental health comorbidities, for example, go into outcome study analysis as well. The same is the case with the type of treatment received, as in the duration and intensity of services provided. 

Outcome study end results are also affected by what people experience and care about. For example, for individuals with chronic conditions where a cure is not always possible, quality of life and mortality are included in the end results. Outcome research can even have become a crucial part of developing better ways to monitor and improve the quality of care. Supporting improvements in health outcomes is a strategic goal of the Agency for Healthcare Research and Quality.

Outcome research has forever transformed the way health care services’ treatment results are evaluated. As a result, we now have a comprehensive and foundational way to measure the quality of care. Now patients and consumers alike can have, for all intents and purposes, “report cards” on these facilities’ quality of care in health plans. Outcome studies also act as a tool for public programs such as Medicaid and Medicare to monitor and improve the quality both in traditional settings and under managed care. 

​​Types of Outcome Measures

There are more outcome measures than you probably realize. From wellbeing, recovery, and cognition to emotions, relationships, and life satisfaction, it’s all about catering to your client. The following are some of the outcome measures implemented by treatment providers:

  • There are clinical outcomes if your symptoms change. The Patient Health Questionnaire 9 (PHQ-9) for depression, the Generalized Anxiety Disorder 7 (GAD-7) for anxiety, or the Posttraumatic Stress Disorder Checklist (PCL-5) for PTSD
  • Global mental health status that is not tied to a specific diagnosis using scales like the Pediatric Symptom Checklist, the Health of the Nation Outcome Scales (HoNOS), the Daily Living Activities Scale (DLA), or the Outcome Questionnaire-45 (OQ-45)
  • Treatment specific measures like the Cognitive Fusion Questionnaire (C.F.Q.) for Acceptance and Commitment Therapy (A.C.T.) and the Difficulties In Emotion Regulation Scale (DERS) for treatment of emotion dysregulation 

Outcomes research is the key to knowing what quality of care we can achieve and how we can achieve it. Only, it has to be done right. 

Shortcomings of Outcome Studies 

Outcome studies can be tricky, however, in that a wrong variable could lead to results that are misleading to a client. This is also why you see a lot of scams involving outcome studies; if insurers and clients like your outcome readings, it means more business and more money.

Clinical outcomes studies, for example, require larger sample sizes than clinical research studies, which opt for other endpoints. You see, for a study to properly detect differences in outcome or to define essential determinants of outcomes, the number of events, not by sample size, matters. So the sample size required in a population with a low incidence of subsequent events is considerably larger than the sample size required in a population with a high event rate. It is for this reason that outcome studies are more difficult to perform.

Similarly, outcome expectation for substance abuse treatment is often confined to the patient’s success in recovery when admitted. However, the real way to know whether substance abuse treatment is working or not is when the data shows positive results beyond the end of the treatment period. Positive outcomes should at least last six to twelve months or at the same points during the course of the outpatient period of care.

It’s not enough to know that patients who stay in treatment longer have better outcomes when the “real world” has less funding and more triggers. The presented research on how highly specialized and resource-intensive treatments “work” on selected samples of patients is irrelevant to treatment providers who do not have access to those treatments and when their documentation doesn’t have records on the already small handful of the patients on whom the specialized treatment was tested.

This is most common with “community-based” public sector treatment programs that are forced to operate under limited budgets with little access to sophisticated services. The reality is that treatment research in these settings of impractical budget constraints and lack of personnel is futile to providers, as the information they gather from their research cannot upgrade or expand their treatment efforts. 

II. Clinical Trials 

What Are Clinical Trials?

Clinical trials are the most comprehensive process to testing therapies that are entirely new to medicine against existing treatments for a given outcome and are performed in people that are aimed at evaluating a medical, surgical, or behavioral intervention. Well-conducted clinical trials evaluate outcomes that genuinely reflect real-world settings and concerns for clinical research to improve patient care. Similarly, well-conducted clinical research has the potential to make a profound impact on client care in general.

Additionally, clinical trials are also the primary way researchers find out if a new treatment, like a new drug, diet, or medical device, is safe and effective in people. Often a clinical trial is used to learn if a new treatment is more effective and/or has less harmful side effects than the standard treatment.

Clinical trials also have the ability to detect diseases early — sometimes even before there are symptoms — as well as make life better for people living with a life-threatening disease or a chronic health problem. Before the U.S. Food and Drug Administration (F.D.A.) approves a clinical trial to begin, for example, scientists perform laboratory tests and studies in animals to test a potential therapy’s safety and efficacy. Once those studies show favorable results, the F.D.A. gives approval for the intervention to be tested in humans.

Clinical trials must go through four phases in order to test a treatment, find the appropriate dosage, and look for side effects. After the first couple of phases, researchers find a drug or other intervention to be safe and effective, then the F.D.A. approves it for clinical use and continues to monitor its effects.

Selecting an appropriate outcome measure is a critical step in designing valid and useful clinical trials and outcome studies. The four phases of clinical trials include:

  • Phase I Trial: A small group of often healthy people (20 to 80) gets to test an experimental treatment for its safety and side effects and to find the correct drug dosage.
  • Phase II Trial: This trial uses more people (100 to 300) and emphasizes effectiveness. That means preliminary data on whether the drug works in people who have a certain disease or condition.
  • Phase III Trial: This trial gathers more information about safety and effectiveness by studying different populations and different dosages. The number of subjects usually ranges from several hundred to about 3,000 people. If the F.D.A. deems test results are positive, it will approve the experimental drug or device.
  • Phase IV Trial: This trial is for drugs or devices and takes place only after the F.D.A. approves their use.  

Clinical Trials Are Difficult

One thing to know about clinical trials is that they aren’t a walk in the park by any means. For starters, clinical trials cost money; then, on top of being costly, they’re time-consuming and often burdensome on patients.

As a result, often trial outcomes are chosen, collected, and reported poorly, leading to meaningless contributions to patient care.

For example, a February 2017 article from JAMA Network shows that 18 of the 36 cancer drugs approved by the U.S. Food and Drug Administration (F.D.A.) from 2008 to 2012 was reportedly clinically meaningless because they used surrogates — which is basically a substitute for an exact measure of how a patient feels, functions, or survives. In this specific case, the tumor shrinkage or progression-free survival studies did not indicate any overall survival (O.S.) benefit. 

As you can see, the surrogate compromises the ability of physicians to make informed treatment decisions and makes evidence difficult or impossible, even, to be contributed to patient care. One way to do this is to ensure that trial outcomes are relevant, appropriate, and important to patients in real-world clinical settings.

Examples of how the types of lapses in outcome reporting include:

  • Surrogate endpoints do not measure the clinical benefit but are expected to predict that clinical benefit.
  • Composite and subjective endpoints are when researchers in a clinical trial decide to combine several measurable outcomes into a single result.
  • Ignoring patients’ perspectives in research outcomes dismisses patients’ attitudes and concerns regarding the ethics of research within medical practice would be to ignore a critical aspect of the process.
  • Publication and other outcome reporting biases occur among a large proportion of published clinical trials, resulting in outcome reporting bias. Selective reporting of outcomes can potentially compromise the validity of a trial and any subsequent meta-analyses.
  • The under-reporting of adverse events incorrectly lowers reporting rates. Factors contributing to under-reporting are numerous and feature country-dependent differences.

The Importance of Measuring Outcomes

Providing data on the outcome of treatment can be essential to long-term recovery for individuals struggling with substance use disorder and any co-occurring mental health disorders. According to Vista Research Group’s publication titled “Using Outcome Measure to Improve Your Addiction Treatment Results,” “outcome measures monitoring appears to make the biggest difference for patients who are not responding as expected to treatment.”

Research from this publication showed that “psychotherapists have a strong tendency to overestimate client improvement.” As a result, clients whose symptoms are not improving can be overlooked. However, when clinicians have access to outcome measures and can see that their clients are not responding as expected, they are more likely to make the necessary changes for successful treatment and recovery. 

Research also found that “among the patients who initially responded poorly to treatment, those whose therapists were monitoring their patients had better outcomes.” Taking information from this study, it is crucial for treatment centers to have access to monitoring data so they can best benefit their clients. 

How Does This Affect Clients?

When treatment staff doesn’t have access to tracking their outcomes or do not do it properly, it is the clients who suffer. If a client is unsure of how effective treatment is at a specific facility, they may pay money or spend time in treatment that does not help them improve substance use disorder or mental health disorder symptoms. Therefore, it is important for individuals and their families to ask treatment centers about any outcome studies they have regarding treatment at their facility.  

The recovery industry is booming and has helped millions of Americans across the country recover from addiction. Unfortunately, this also means competitors have come into the business who do not have the best interest of clients in mind. Lack of outcome studies for treatment efficacy is one way the recovery industry is failing clients. When inadequate and unethical outcome studies come into play, it is clients who suffer. As a result, they may not find successful recovery or seek treatment from a facility that participates in other unethical practices. At Whitehouse Recovery and Detox, we want those looking for life-saving substance abuse treatment to find the care they need. We want to educate you on how the recovery industry is failing, so you or a loved one do not get harmed in the process of trying to find care. For more information on the treatment industry and the importance of outcome studies, call us today at (800) 510-5393.

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