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Can Addiction Research Be Trusted?. Introducing EBAM* (*Evidence Based Addiction Medicine). Stewart B. Leavitt, PhD, Editor Addiction Treatment Forum Sponsored by an educational grant from Mallinckrodt Inc. EBAM Guides Available. “Can Addiction Research Be Trusted?” – report

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Can Addiction Research Be Trusted?

Introducing EBAM*(*Evidence Based Addiction Medicine)

Stewart B. Leavitt, PhD, EditorAddiction Treatment Forum

Sponsored by an educational grant from Mallinckrodt Inc.


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EBAM Guides Available

  • “Can Addiction Research Be Trusted?” – report

  • Available online at www.atforum.com

  • Look under Addiction Resources tab

  • Slides from this presentation also available

    • Called “EBAM AATOD Slides”

    • PowerPoint format


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“EBAM for Practitioners”

  • Available at… www.atforum.com under “Addiction Resources” tab.

  • A more technical explanation for persons who need to critically assess research evidence.


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Can Addiction ResearchBe Trusted?Yes? No? Sometimes?

  • Research must be critically examined and interpreted for particular clinical needs and patient benefits.

  • Just because something appears in print does not mean it is worthwhile or valid.


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Why Should You Care?

  • Research directly or indirectly affects the practice of addiction medicine on a daily basis.

  • There is an urgent need forgood science to overcome stigma, prejudice, and misunderstanding.

Trepanation once was a “scientific cure” formental illness.


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What is EBAM?Evidence-Based Addiction Medicine

  • The use of current best evidence in making decisions about the care of patients.

  • Involves combining clinical expertise with valid research on a topic of concern.

  • Differentiates between practices based on sound evidence versus those founded more on 1) tradition, 2) outdated beliefs, or 3) “junk” science.


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Why EBAM?

EBAM approaches allow you to respond more convincingly to the following questions….

  • Where did you hear about that treatment?

  • How do you know the information is worthwhile and true?

  • What do you propose doing and what results do you expect?

  • What are the costs versus benefits?


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Essential Understandings

  • Medical research is an imperfect science.

  • Medical writing/reporting is often biased.

  • Scientific research does not “prove” anything to be true or not true.


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The Nature of Clinical Research

  • Compares experimental treatment (intervention) with standard therapy or placebo.

  • Research subjects represent only a tiny portion of the population in question – statistical analyses estimate effects in the larger population.

  • All things are possible (some patients recover without treatment), and chance can play an important role in the results.


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Interpreting Research

  • Interpretation is a matter of perception.

  • Not everyone “sees” a research study in the same way.

  • Becoming a more critical consumer of research is essential.


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Problems with Medical Research Articles Overall

Surveys of research have found startling results…

  • On average, half or more of journal articles contain errors – from missing data to major design flaws.

  • Roughly, up to 2/3 of article abstracts may contain data that is either inconsistent with or missing from the main body of the article.

  • In one investigation, 80% of systematic reviews & meta-analyses examined had serious flaws.


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Concerns About Addiction Research Studies

  • Many articles appear to be written for other researchers, rather than practitioners.

  • There are often too few subjects and/or inadequate effects for accurately detecting significant group differences.

  • Subjects are often selected to maximize outcome results, but they are not typical patients.

  • Cases are presented as if they are evidence of causality or applicable to broader groups.

  • There may be a biased leap of interpretation from laboratory experiments to potential effects in humans.


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What Really Matters?

  • “Not everything that can be counted counts, and not everything that counts can be counted. What really mattersis not always obvious.”– Albert Einstein

  • Just because data were collected, analyzed, and reported does not mean they are relevant to the clinical question at hand – but it mattered to somebody.


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What Are Significant Outcomes?

  • Statistical Significance – the likelihood (probability) that the results represent true differences between groups.

  • Clinical Significance – importance of the results for providing meaningful benefits to patients.

  • Statistical significance does not automatically transfer to clinical significance.


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Taking A Closer LookAtClinical Research Articles


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Anatomy of a Research Article

Abstract

Introduction

Methods

Results

Discussion

Conclusion


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Abstract

  • Presents overview: who, what, where, when, why, and how.

  • Structured abstract is a mini-article…

    • Summarizes major sections of article.

    • Limited to 250 words.

  • Abstract may be inaccurate & misleading.


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Introduction

  • States purpose of study, including:

    • clinical background,

    • review of previous research,

    • rationale for current investigation.

  • Identifies questions (hypotheses) to be investigated in present study.


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Methods

  • Defines the patients (subjects) included in the study and the sample sizes.

  • Describes in detail how the study was conducted (treatment protocol).

  • Defines outcomes of importance and how they were measured.

  • Describes how data was analyzed (statistics).


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Results

  • Describes in detail what was found:

    • differences in treatment effects (outcomes),

    • their significance (p values),

    • and, confidence limits.

  • Should show how statistical procedures were performed and any data adjustments (eg, for noncompliant/dropout subjects).


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Discussion

  • Recaps results (the “payoff”).

  • Interprets findings in comparison with other research on the topic.

  • Describes study limitations.

  • Notes other factors that might have influenced outcomes.


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Conclusion

  • Presents case for “external validity” – how, when, where, and in which patients the results might be applied in clinical settings.

  • Often provides suggestions for further research on the subject.


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Hierarchy of EvidenceClinical Therapy Research

Systematic Reviews / Meta-Analyses of RCTs.

Randomized Controlled Trials (RCTs).

Cohort Studies

Case-Control Studies

Cross-Sectional Surveys

Case Reports

“Perspectives” Articles


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“Perspectives” Articles

  • Aka* overviews, reports, commentary, editorials, or interviews. *Also known as…

  • Most common in addiction field; often cited as evidence.

  • Summarize or comment on research, and are the most subject to bias.

  • Usually, favors one viewpoint (perspective) over another.


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“The Emperor’s NewPerspective (Clothes)”

  • “He thought it better to continue the illusion that anyone who couldn’t see his clothes was either stupid or incompetent.” – H.C. Anderson

  • Sometimes, the higher the “authority” of the source, theless its perspective can be trusted as being valid and unbiased.


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Case Reports

  • Aka case histories, case series, or anecdotes.

  • Draw upon personal observations or medical records to report unexpected events.

  • Subject to errors in observation or interpretation, or inadequate documentation.

  • May arrive at unsupported conclusions.

  • “The plural of anecdote is not evidence.” – Leshner


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Cross-Sectional Surveys

  • Aka prevalence or epidemiology studies.

  • Examines relationships of medical conditions, treatments, and/or other factors in a patient population at a particular time.

  • Can establish associations but not causality.

  • May be problems with recall and extraneous factors (confounders).


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Case-Control Studies

  • Aka case-referent, case-comparison, or retrospective studies.

  • Identifies patients with outcome of interest (Cases) and Control patients without the outcome.

  • Researchers look back in time to see how the two groups differed (especially, regarding treatment or exposure received).

  • Subject to recall bias or inconsistent records.


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A “Classic” Case-Control Study

  • 25 persons (Cases) exposed to Tutankhamen’s tomb in 1923-26.

  • Compared with 11 explorers in Egypt at that time not exposed (Controls).

Results: No significant differences in mean age at death or in years survival after exposure.

Conclusion: Mummy’s curse was an urban legend.


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Cohort Studies

  • Aka followup, incidence, longitudinal, observational, or prospective studies.

  • Most common trial in addiction medicine.

  • An Experimental group (cohort) receives treatment of interest; Control group does not.

  • Outcome differences between groups are compared and contrasted.

  • Nonrandomized, many factors uncontrolled.


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A First (?) Clinical Cohort Trial

  • In 1774, a ship’s doctor took 12 sailors with scurvy and treated them daily, 2 at a time, with either…

    • …cider, elixir vitriol, vinegar, sea water, nutmeg, or oranges/lemons.

    • Compared with untreated patients.

  • Citrus fruit provided rapid relief.


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Randomized Controlled Trials

  • RCTs considered “gold standard.”

  • Subjects randomized to Experimental and Control conditions; then followed for outcomes.

  • Extraneous factors (confounders) are equally distributed across groups.

  • Subjects/investigators usually “blinded.”

  • May be ethical concerns about Control condition.


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Systematic Reviews& Meta-Analyses

  • Gather highest quality evidence on a subject.

  • Compare and contrast studies to reach summary statements and conclusions.

  • Meta-analyses combine statistical evidence from multiple studies for greater precision.

  • Conclusions tend to be reliable and accurate.

  • Clinical guidelines often come from these studies.


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A Closer LookAtClinical Research Validity


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What is Validity?

  • The degree to which the research represents the most accurate and bias-free treatment effects.

  • Internal Validity – refers to effects that are valid for the subjects in the particular study.

  • External Validity – refers to the relevance of a study for typical addiction treatment settings.

  • Validity is determined by looking at a study’s design and sources of potential bias.


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What is Bias?

  • Bias is anything that influences conclusions about the groups under investigation and potentially distorts comparisons.

  • The question is not if there is bias, buthow much and whether it is sufficient to make the study invalid for a particular purpose.


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Publication Bias – Trials with “positive” results are more likely to be submitted and published more quickly.

Patient Selection – Who was excluded or included? Were groups equivalent?

Subject Management – Were groups treated exactly the same, except for the intervention under study?

Sources of Potential Bias - 1


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Sources of Potential Bias - 2

  • Randomization – Subjects should have an equal chance of assignment to each study condition.

  • Blinding (Masking) – Avoids preconceived ideas about treatment effects.

  • Placebo Effects – Mere expectation of benefit (or harm) may influence outcomes.


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Sources of Potential Bias - 3

  • Confounding Factors – Extraneous factors, known or unknown, may cause certain effects to occur or not to occur.

  • Compliance/Follow-up – Adherence to protocol and retention in study are critical.

  • Completeness of Data – Are all or only some subjects analyzed? (ITT vs Per Protocol)


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Overcoming “Statistophobia”

  • When most people hear the wordstatistics they want to hide.

  • It is not necessary to be a biostatistician to understand and assess addiction research.


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Example: How Large Is TheTreatment Benefit?

  • RCT comparing 8 mg/d buprenorphine (BUP) vs 80 mg/d methadone (M80).

  • Average illicit-opioid+ urinalyses at 26 weeks.

  • M80 produced significant 17% reduction.(55% - 38% = 17%; p < .01)

Ling et al. Arch Gen Psychiatry. 1996;53:401-407.


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Example: How Many Patients Need To Be Treated?

  • Treatment effect = 17% reduction with M80.

  • For every 100 patients treated with M80, rather than BUP, 17 more would benefit.

  • That is… …for every 6 patients (100 ÷ 17) treated with M80, one additional patient would remain illicit-opioid abstinent than if treated with BUP.


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What The Article Didn’t Say

In the 8 mg/d BUP vs 80 mg/d Methadone trial –

  • The patients selected were ideal; rather than typical.

  • There was a 95% chance that the “true” treatment effect was between 7% and 28% (vs 17% reported).

  • Not enough subjects enrolled (n=150) to accurately detect the relatively small treatment effect of 17%.

  • So many subjects dropped out that the validity should be questioned. (48% M80, 65% BUP gone at 26 wks)


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Why DoesGood ResearchGo Bad?


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Researcher-WritersFace Challenges

  • Insufficient funding – researchers may choose to do “something” when funds are not available to do it “right.”

  • Inadequate training in research & reporting.

  • Lack of technical support – many researchers do not have access to data processing and statistical support staff.


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Researcher-WritersFace Challenges (Cont.)

  • “Publish or perish” pressures – influence poor quality in design and reporting.

  • Political agendas – promote certain lines of research looking for “desired” results.

  • Journal space limitations – foster inadequate descriptions of analyses and results.

  • “Too many cooks” – multiple authors and peer reviewers complicate the process.


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Research Writing Run Amok

When too many people are involved in a research article, it reminds us that…

“A camel is a horse that was designed by a committee.”


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Dangers of “Data Dredging”

  • Searching for “significant results” after the study is over and the findings were not as expected or desired (post hoc analysis).

  • Analyzing the same data in different ways until something “important” turns up.

  • Cranking-out several articles from a single small clinical study.


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Laboratory vs Clinical Research

  • Test tube & animal results do not necessarily apply to people.

  • “Bench work” can be invaluable for guiding clinical trials in humans.

  • But the ultimate test is in patients “at the bedside.”

©1980, David Sinclair, PhD - used by permission


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Distortions in the Mass Media“Medical Propaganda”

  • Medical journalists usually lack understanding of research methods and shortcomings.

  • News editors seek sensational health stories to grab the public’s attention.

  • Research organizations and publications should be more cautious in their reporting of research to the press.

  • Readers need to become more critical.


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PuttingAddiction ResearchInto Practice


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Judging Everyday Relevance

  • Is the article of high quality and valid?

  • Does the study relate to your clinical needs?

  • Are the participants similar to your own patients?

  • Is the approach used in the study clearly explained and free of bias?

  • Are the results understandable and significant?

  • Do the conclusions make sense and suggest clear benefits for patient care?


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Develop A Healthy Skepticism

  • Learn to trust your educated instincts.

  • If it sounds like a duck, and walks like a duck, but smells like a fish… …something is probably a bit “fishy.”


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What Else Can You Do?

  • Only support/subscribe to publications offering high-quality, well-documented research evidence.

  • Lobby NIDA & other funding organizations to provide clinically-relevant research of the best quality in design and reporting.

  • Challenge “fishy” reports in the media or from other sources – write letters.


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“Bible” for Medical Authors

  • AMA style book is the “gold standard” for medical writing.

  • Depicts correct formats for research papers, plus a wealth of other info.

  • Differs from other styles used in behavioral and social sciences.


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E-BM Guidebook

  • Users’ Guides to the Medical Literature(Textbook with CD-ROM)

  • Available at:

    • www.usersguides.org

    • www.amazon.com

  • Presents all aspects of evidence-based medicine.


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“EBAM for Practitioners”

  • Available at… www.atforum.com under “Addiction Resources” tab.

  • A more technical explanation for persons who need to critically assess research evidence.


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Can Addiction Research Be Trusted?Usually!IF you learn what tolook for.

“We have met the enemy and he is us!” - Pogo (Walt Kelly)


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Sponsored by an educational grant from Mallinckrodt Inc.


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