California Code of Regulations › Title 8 - Industrial Relations › Division 1 - Department of Industrial Relations › Chapter 4.5 - Division of Workers' Compensation › Subchapter 1 - Administrative Director-Administrative Rules › Article 5.5.2 - Medical Treatment Utilization Schedule › Section 9792.25 - Quality and Strength of Evidence - Definitions

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) For purposes of sections
					 9792.25-9792.26, the following
					 definitions shall apply:
(1) "Appraisal of
					 Guidelines for Research & Evaluation II (AGREE II) Instrument" means a tool
					 designed primarily to help guideline developers and users assess the
					 methodological rigor and transparency in which a guideline is developed. The
					 Administrative Director adopts and incorporates by reference the Appraisal of
					 Guidelines for Research & Evaluation II (AGREE II) Instrument, May 2009
					 into the MTUS from the following website:
www.agreetrust.org
. A copy of the Appraisal of
					 Guidelines for Research & Evaluation II (AGREE II) Instrument, May 2009
					 version may be obtained from the Medical Unit, Division of Workers'
					 Compensation, P.O. Box 71010, Oakland, CA 94612-1486, or from the DWC web site
					 at
http://www.dwc.ca.gov
.
(2) "Bias" means any tendency to influence
					 the results of a trial (or its interpretation) other than the experimental
					 intervention. Biases include but are not limited to vested interests such as
					 financial interests, academic interests, and industry influence; confounding
					 variables, inadequate generation of the randomization sequence, inadequate
					 concealment of allocation, selection, lack of blinding, selective outcome
					 reporting, failure to do intention-to-treat analysis, early stopping, and
					 publication.
(3) "Biologic
					 plausibility" means the likelihood that existing biological, medical, and
					 toxicological knowledge explains observed effect.
(4) "Blinding" means a technique used in
					 research to eliminate bias by hiding the intervention from the patient,
					 clinician, and any others who are interpreting results.
(5) "Case-control study" means a
					 retrospective observational epidemiologic study of persons with the disease (or
					 other outcome variable) of interest and a suitable control (comparison,
					 reference) group of persons without the disease. The relationship of an
					 attribute to the disease is examined by comparing the diseased and non-diseased
					 with regard to how frequently the attribute is present or, if quantitative, the
					 levels of the attribute, in each of the groups.
(6) "Case report" means a detailed report of
					 the symptoms, signs, diagnosis, treatment, and follow-up of an individual
					 patient. Case reports usually describe an unusual or novel
					 occurrence.
(7) "Case-series" means
					 a group or series of case reports involving patients who were given similar
					 treatment. Reports of case series usually contain detailed information about
					 the individual patients. This includes demographic information (for example,
					 age, gender, ethnic origin) and information on diagnosis, treatment, response
					 to treatment, and follow-up after treatment. This may be done prospectively or
					 retrospectively.
(8) "Cohort study"
					 (also known as "follow-up study" or "prospective study") means an epidemiologic
					 study in which two or more groups of people that are free of disease and that
					 differ according to the extent of exposure to a potential cause of the disease
					 are compared with respect to the incidence (occurrence of the disease) in each
					 of the groups. This may include a comparison of treated and non-treated
					 patients. The main feature of cohort study is observation of large numbers of
					 people over a long period of time (commonly years) with comparison of incidence
					 rates in groups that differ in exposure levels.
(9) "Concealment of allocation" means
					 precautions taken to ensure that the groups to which patients or subjects are
					 assigned as part of a study are not revealed prior to definitively allocating
					 them to their respective groups.
(10) "Confounding variable" means extrinsic
					 factor associated with the exposure under study and cause of the
					 outcome.
(11) "Cross-sectional
					 study" means a study that examines the relationship between diseases (or other
					 health-related characteristics) and other variables of interest as they exist
					 in a defined population at one particular time. Note that disease prevalence
					 rather than disease incidence is normally recorded in a cross-sectional study.
					 The temporal sequence of cause and effect cannot necessarily be determined in a
					 cross-sectional study.
(12)
					 "Diagnostic test" means any medical test performed to confirm, or determine the
					 presence of disease in an individual suspected of having the disease, usually
					 following the report of symptoms, or based on the results of other medical
					 tests. Some examples of diagnostic tests include performing a chest x-ray to
					 diagnose pneumonia, and taking skin biopsy to detect cancerous cells.
(13) "Disease incidence" means new cases of
					 disease or condition over a period of time.
(14) "Disease prevalence" means rate of a
					 disease or condition at any particular point in time.
(15) "Expert opinion" means a determination
					 by experts, through a process of evidenced-based thinking, that a given
					 practice should or should not be recommended, and the opinion is published in a
					 peer-reviewed medical journal.
(16)
					 "Inception cohort study" means a group of individuals identified for subsequent
					 study at an early, uniform point in the course of the specified health
					 condition, or before the condition develops.
(17) "Index test" means the diagnostic
					 procedure or test that is being evaluated in a study.
(18) "Intention to treat" means a procedure
					 in the conduct and analysis of randomized controlled trials. All patients
					 allocated to a given arm of the treatment regimen are included in the analysis
					 whether or not they received or completed the prescribed regimen. Failure to
					 follow this step defeats the main purpose of random allocation and can
					 invalidate the results.
(19) "Low
					 risk of bias" means those trials or studies that contain methodological
					 safeguards to protect against biases related to vested interests such as
					 financial interests, academic interests, industry influence, or other biases
					 related to the generation of the randomization sequence, concealment of
					 allocation, selection, blinding, selective outcome reporting, early stopping,
					 and intention to treat.
(20)
					 "Meta-analysis" means a mathematical process whereby results from two or more
					 studies are combined using a method that provides a weight to each study that
					 reflects the statistical likelihood (variance) that its results are more likely
					 to be closer to the truth.
(21)
					 "Post-marketing surveillance" means a procedure implemented after a drug has
					 been licensed for public use. The procedure is designed to provide information
					 on the actual use of the drug for a given indication and on the occurrence of
					 side effects, adverse reactions, etc. This is a method for identifying adverse
					 drug reactions, especially rare ( < 1% incidence) ones.
(22) "Prognosis" means the prospect of
					 survival and recovery from a disease as anticipated from the usual course of
					 that disease or indicated by special features of the case.
(23) "Randomized trial" means a clinical
					 experiment in which subjects in a population are allocated by chance into
					 groups, usually called study and control groups, to receive or not receive an
					 experimental diagnostic, preventive, or therapeutic procedure, maneuver, or
					 intervention. The results are assessed by comparison of rates of disease,
					 death, recovery, or other appropriate outcome in the study and control
					 groups.
(24) "Reference standard"
					 means the gold standard to which an index test is being compared.
(25) "Risk of bias" means a term that refers
					 to the advertent or inadvertent introduction of bias into trials because of
					 methodological insufficiencies to protect against biases related to vested
					 interests such as financial interests, academic interests, industry influence,
					 or other biases related to the generation of the randomization sequence,
					 concealment of allocation, selection, blinding, selective outcome reporting,
					 early stopping, and intention to treat.
(26) "Selective outcome reporting" means the
					 failure to report all of the outcomes that are assessed in a trial, including a
					 post hoc change in the primary outcome.
(27) "Systematic review" means the
					 application of strategies that limit bias in the assembly, critical appraisal,
					 and synthesis of all relevant studies on a specific topic. Systematic reviews
					 focus on peer-reviewed publications about a specific health problem and use
					 rigorous, standardized methods for selecting and assessing articles. A
					 systematic review differs from a meta-analysis in not including a quantitative
					 summary of the results. However, a meta-analysis may be part of a systematic
					 review.
(28) "Treatment benefits"
					 means positive patient-relevant outcome associated with an intervention,
					 quantifiable by epidemiological measures such as absolute risk reduction and
					 number needed to treat.
(29)
					 "Treatment harms" means an adverse patient-relevant outcome associated with an
					 intervention, identifiable by epidemiological measures such as absolute
					 increased risk of occurrence or number needed to harm if possible, but also
					 identifiable by post-marketing surveillance.