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Chapter 4.5. Division of Workers' Compensation
Subchapter 1. Administrative Director--Administrative Rules
Article 5.5.2. Medical treatment utilization schedule
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§9792.25. Presumption of Correctness, Burden of Proof and Strength of Evidence.

(a) The MTUS is presumptively correct on the issue of extent and scope of medical treatment and diagnostic services addressed in the MTUS for the duration of the medical condition. The presumption is rebuttable and may be controverted by a preponderance of scientific medical evidence establishing that a variance from the schedule is reasonably required to cure or relieve the injured worker from the effects of his or her injury. The presumption created is one affecting the burden of proof.

(b) For all conditions or injuries not addressed by the MTUS, authorized treatment and diagnostic services shall be in accordance with other scientifically and evidence-based medical treatment guidelines that are nationally recognized by the medical community.

(c)(1) For conditions or injuries not addressed by either subdivisions (a) or (b) above; for medical treatment and diagnostic services at variance with both subdivisions (a) and (b) above; or where a recommended medical treatment or diagnostic service covered under subdivision (b) is at variance with another treatment guideline also covered under subdivision (b), the following ACOEM's strength of evidence rating methodology is adopted and incorporated as set forth below, and shall be used to evaluate scientifically based evidence published in peer-reviewed, nationally recognized journals to recommend specific medical treatment or diagnostic services:

  (A) Table A - Criteria Used to Rate Randomized Controlled Trials  


  Studies shall be rated using the following 11 criteria. Each criterion shall be rated 0, 0.5, or 1.0, thus the overall ratings range from 0-11. A study is considered low quality if the composite rating was 3.5 or less, intermediate quality if rated 4-7.5, and high quality if rated 8-11.  

Criteria

Rating Explanation

 

Randomization:
Assessment of the degree that randomization was both reported to have been performed and successfully* achieved through analyses of comparisons of variables between the two groups.

*Simply allocating individuals to groups does not constitute sufficient grounds to assess the success of randomization. The groups must be comparable; otherwise, the randomization was unsuccessful.

 

Rating is “0” if the study is not randomized or reports that it was and subsequent analyses of the data/tables suggest it either was not randomized or was unsuccessful.

Rating is “0.5” if there is mention of randomization and it appears as if it was performed, however there are no data on the success of randomization, it appears incomplete, or other questions about randomization cannot be adequately addressed.

Rating is “1.0” if randomization is specifically stated and data reported on subgroups suggests that the study did achieve successful randomization.

 

Treatment Allocation Concealed:
Concealment of the allocation scheme from all involved, not just the patient. 

 

Rating is “0” if there is no description of how members of the research team or subjects would have not been able to know how they were going to receive a particular treatment, or the process used would not be concealed. 

Rating is “0.5” if the article mentions how allocation was concealed, but the concealment was either partial involving only some of those involved or other questions about it are unable to be completely addressed. 

Rating is “1.0” if there is a concealment process described that would conceal the treatment allocation to all those involved.

 

Baseline Comparability: Measures how well the baseline groups are comparable (e.g., age, gender, prior treatment). 

 

Rating is “0” if analyses show that the groups were dissimilar at baseline or it cannot be assessed. 

Rating is “0.5” if there is general comparability, though one variable may not be comparable. 

Rating is “1.0” if there is good comparability for all variables between the groups at baseline.

 

Patient Blinded

 

Rating is “0” if there is no mention of blinding of the patient.

Rating is “0.5” if it mentions blinding, but the methods are unclear.

Rating is “1.0” if the study reports blinding, describes how that was carried out, and would plausibly blind the patient.

 

Provider Blinded

 

Rating is “0” if there is no mention of blinding of the provider. 

Rating is “0.5” if it mentions blinding, but the methods are unclear. 

Rating is “1.0” if the study reports blinding, describes how that was carried out and would plausibly blind the provider.

 

Assessor Blinded

 

Rating is “0” if there is no mention of blinding of the assessor.

Rating is “0.5” if it mentions blinding, but the methods are unclear.

Rating is “1.0” if the study reports blinding, describes how that was carried out and would plausibly blind the assessor.

 

 

Controlled for Co-interventions: The degree to which the study design controlled for multiple interventions (e.g., a combination of stretching exercises and anti-inflammatory medication or mention of not using other treatments during the study).

Rating is “0” if there are multiple interventions or no description of how this was avoided.

Rating is “0.5” if there is brief mention of this potential problem.

Rating is “1.0” if there is a detailed description of how co-interventions were avoided.

 

Compliance Acceptable: Measures the degree of non-compliance.

 

Rating is “0” if there is no mention of non-compliance.

Rating is “0.5” if non-compliance is briefly addressed and the description suggests that there was compliance, but a complete assessment is not possible.

Rating is “1.0” if there are specific data and the non-compliance rate is less than 20%.

 

 

Dropout Rate:
Measures the drop-out rate.

 

Rating is “0” if there is no mention of drop-outs or it cannot be inferred from the data presented.

Rating is “0.5” if the drop-out issue is briefly addressed and the description suggests that there were few drop-outs, but a complete assessment is not possible.

Rating is “1.0” if there are specific data and the drop-out rate is under 20%.

 

Timing of Assessments: Timing rates the timeframe for the assessments between the study groups.

 

Rating is “0” if the timing of the evaluations is different between the groups.

Rating is “0.5” if the timing is nearly identical (e.g., one day apart). 

Rating is “1.0” if the timing of the assessments between the groups is identical.

 

 

Analyzed by Intention
to Treat:
This rating is for whether the study was analyzed with an intent to treat analysis.

Rating is “0” if it was not analyzed by intent to treat.

Rating is “0.5” if there is not mention of intent to treat analysis, but the results would not have been different (e.g., there was nearly 100% compliance and no drop-outs).

Rating is “1.0” if the study specifies analyses by intention to treat. 

 

 

Lack of Bias:
This rating does not enter into the overall rating of an article. This is an overall indication of the degree to which biases are felt to be present in the study.

 

Rating is “0” if there are felt to be significant biases that are uncontrolled in the study and may have influenced the study’s results.

Rating is “0.5” if there are felt to be some biases present, but the results are less likely to have been influenced by those biases.

Rating is “1.0” if there are few biases, or those are well controlled and unlikely to have influenced the study’s results.


  (B) Table B - Strength of Evidence Ratings  


  Levels of evidence shall be used to rate the quality of the body of evidence. The body of evidence shall consist of all studies on a given topic that are used to develop evidence-based recommendations. Levels of evidence shall be applied when studies are relevant to the topic and study working populations. Study outcomes shall be consistent and study data shall be homogeneous.  

 

 

A

 

Strong evidence-base: One or more well-conducted systematic reviews or meta-analyses, or two or more high-quality studies.

 

B

 

Moderate evidence-base: At least one high-quality study, a well-conducted systematic review or meta-analysis of lower quality studies or multiple lower-quality studies relevant to the topic and the working population.

 

 

C

 

Limited evidence-base: At least one study of intermediate quality.

 

I

 

Insufficient Evidence: Evidence is insufficient or irreconcilable.

 



  (2) Evidence shall be given the highest weight in the order of the strength of evidence.  


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


 HISTORY 
   
1. Renumbering and amendment of former section 9792.22 to new section 9792.25 filed 6-18-2009; operative 7-18-2009 pursuant to  Government Code section11343.4 (Register 2009, No. 25).

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