Cal. Code Regs. Tit. 8, § 9792.25 - Quality and Strength of Evidence - Definitions

(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.

Notes

Cal. Code Regs. Tit. 8, § 9792.25

1. Renumbering and amendment of former section 9792.22 to new section 9792.25 filed 6-18-2009; operative 7-18-2009 (Register 2009, No. 25).
2. Editorial correction of operative date in HISTORY 1 (Register 2009, No. 30).
3. Amendment of section heading and repealer and new section filed 4-20-2015; operative 4-20-2015 pursuant to Government Code section 11343.4(b)(3) (Register 2015, No. 17).

Note: Authority cited: Sections 133, 4603.5, 5307.3 and 5307.27, Labor Code. Reference: Sections 77.5, 4600, 4604.5 and 5307.27, Labor Code.

1. Renumbering and amendment of former section 9792.22 to new section 9792.25 filed 6-18-2009; operative 7-18-2009 (Register 2009, No. 25).
2. Editorial correction of operative date in History 1 (Register 2009, No. 30).
3. Amendment of section heading and repealer and new section filed 4-20-2015; operative 4/20/2015 pursuant to Government Code section 11343.4(b)(3) (Register 2015, No. 17).