<h3><b>The Panels</b></h3><p>In 2002, a taskforce assembled between the AAPB and ISNR trade organizations developed guidelines for assessing the efficacy of neurofeedback and biofeedback interventions. The article is made available&nbsp; within this chapter. At the outset of this article, the establishment of panels of competent professionals from the psychophysiological community (and adjunctive fields) is detailed. In their evaluation of the neurotherapy treatment modality, each panel will have discretion over "their process and method, determining
the target condition, patient population, interventions to be included and/or excluded, provider type, and service settings."</p><p>The "Template" notes that neurofeedback assessments ought to use quantitative EEG (or similar measures) to identify abnormal patterns of cortical activity. Understanding how the EEG creates the QEEG lends the practitioner a heightened level of clinical assessment in understanding the waveforms that cause the quantitative and normative version of the data.&nbsp;</p><h4><b>Efficacy: Having the Desired Effect</b></h4><p>the fundamental requirements to determine efficacy include:</p><p><ul><li><span style="font-size: 1rem;">Basic
knowledge of clinical experimental design and analysis methods as well as ethical standards for human research</span></li><li><span style="font-size: 1rem;">A fundamental level of training
and education, possession of a foundation of relevant knowledge, and effective clinical assessment skills</span></li></ul></p><h4><b>Scientific Considerations</b></h4><p>Each experiment / assessment must specify&nbsp;</p><p><ol><li>The independent variables (e.g., sensor placement, bandwidths
and frequencies, reinforcement contingencies)</li><li>The dependent variables (e.g., physiological
event being measured, response to treatment).</li><li>The “condition of interest” (COI), clearly identified and operationally defined</li><li>Guidelines specific to the modality under review</li><li>The modality's amenability to replicability and empirical analysis</li><li>Expected outcomes in identified variables</li><li>Identification of important variables</li><li>Outcome measures</li></ol></p><h4><b>Specificity</b></h4><p><span>1) Determination as to whether a particular treatment component is necessary to the treatment
outcome,</span></p><p><span>2) Whether “Placebo” nonspecificity can be ruled out as
the dominant effect</span></p><h4><b>Clinical Utility</b></h4><p><span>Panels must determine the following:</span></p><p><span>1. Efficacy (having the desired effect) refers to the determination of treatment effect
derived from a systematic evaluation obtained in a controlled clinical trial.&nbsp;</span></p><p><span>2. Clinical utility refers to the practical value of an intervention, or the extent to
which it is practical and possible to translate the findings from efficacy studies<br></span></p><h4><span><b>HIERARCHY OF EVIDENCE: CLINICAL TRIALS AND EFFICACY STUDIES</b></span></h4><p><span><b>There is a generally accepted hierarchy
of “scientific power” for each clinical trial design.<br></b></span></p><p><span><b></b></span></p><p></p><ol><li><b style="font-size: 1rem;">Anecdotal Evidence</b><span style="font-size: 1rem;">: This is a narrative
report about a particular treatment that worked. This is not considered scientifically
rigorous.</span></li><li><b style="font-size: 1rem;">Uncontrolled Case Study</b><span style="font-size: 1rem;"> This will specify
the dependent and independent variables and, ideally, will include quantitative
pre-post measures, as well as follow-up measures. This is not considered scientifically
strong.</span></li><li><b style="font-size: 1rem;">Historical Control</b><span style="font-size: 1rem;">: An example of an
effective historical control might be a disorder or disease that is known to be
so universally lethal (Ebola virus, hemorrhagic fever) or debilitating (e.g.,
Alzheimer’s Disease) that any intervention that increases survival rate or
prolongs quality of life is regarded as efficacious.</span></li><li><b style="font-size: 1rem;">Observational Studies</b><span style="font-size: 1rem;">: These include retrospective
or prospective studies that are case-controlled but not randomized or blinded,</span></li><li><b style="font-size: 1rem;">Waitlist or “intention to treat” controls</b></li><li><b style="font-size: 1rem;">Within-subject and intrasubject replication
designs</b><span style="font-size: 1rem;"> (i.e the A-B-A design)</span></li><li><b style="font-size: 1rem;">Single blind, random assignment control
design, either sham or active</b><span style="font-size: 1rem;"> (behavioral, psychological, or
pharmacological) </span><b style="font-size: 1rem;">treatment</b><span style="font-size: 1rem;"> controls. This design “blinds” the subject to
the particular treatment condition to which they have been assigned, thus
controlling for some of the nonspecific subject variables that may operate in
the study (expectancy, acquiescent response bias, etc.). It does not control
for experimenter bias.</span></li><li><b style="font-size: 1rem;">Double blind control studies, sham or active
controls, random assignment. </b><span style="font-size: 1rem;">This design “blinds” both the subject and the
experimenter to the treatment condition, thus controlling for both subject
variables and experimenter bias.</span></li><li><b style="font-size: 1rem;">Treatment Equivalence or Treatment
Superiority Designs</b><span style="font-size: 1rem;">: This design compares the investigational treatment to
a known and accepted standard treatment.</span></li><li><b style="font-size: 1rem;">Other Designs</b><span style="font-size: 1rem;">: Other more sophisticated
clinical trial designs</span></li></ol><p></p><p><!--[if !supportLists]--><b></b></p>

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<p><b>Criteria for Levels of Evidence of Efficacy</b></p>

<p>Level 1: Supported only by anecdotal reports and/or case
studies in nonpeer reviewed venues. Not empirically supported.</p>

<p>Level 2: Possibly Efficacious</p>

<p>Level 3: Probably Efficacious</p>

<p>Level 4: Efficacious</p>

<p>Level 5: Efficacious and Specific</p>

<p><b>Ethical Standard for Research</b></p>

<p>Finally, the panels will examine the research reports in
light of published ethical standards governing human subject research (i.e.
Declaration of Helsinki, published by the World Medical Association (2000), and
the Belmont Report (1979), published by the Department of Health and Human
Services).<b></b></p><h3><b></b></h3>