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rapidGRADE: An easy to use evidence grading system for any test or therapy

Oliver Zolman MD

Introducing rapidGRADE

GRADE (Grading quality of evidence and strength of recommendations) is the gold standard for evaluating how effective a treatment is.

However, it seems too complex for many people to use, especially non-professional scientists, and can be time intensive to do. So I invented rapidGRADE.

rapidGRADE is a faster, simplified version of doing GRADE that anyone can do with minimal training.

It also extends the original GRADE to safety (rapidGRADE SAFETY) and diagnostic test accuracy (rapidGRADE TEST ACCURACY), on top of the rapidGRADE EFFICACY

rapidGRADE can be done with minimal training such that even journalists, bloggers/vloggers, patients with no scientific background can use it, or time strapped clinicians, students or trainees can do it .

Each of rapidGRADE EFFICACY, rapidGRADE SAFETY, rapidGRADE TEST ACCURACY are scored out of 5, with 5 being the best score for efficacy, safety or accuracy.

rapidGRADE can only be applied to specific outcomes and populations 

Note, like GRADE, for different outcomes and different subpopulations you need to calculate a separate rapidGRADE score.

So for example you would need to calculate a rapidGRADE separately for each of the following

Metformin for diabetics preventing stroke

Metformin for diabetics preventing raise in HbA1c

Metformin for pre-diabetics preventing raise in HbA1c

Metformin in non-diabetic, non-prediabetics for preventing stroke

rapidGRADEs MUST be only applied to a specific population and outcome!

rapidGRADE EFFICACY

Effectiveness score out of 5

1/5 = animal data effectiveness

2/5 = any non randomised peer reviewed human data effectiveness

3/5 = small effectiveness in randomised human data (0.2 - 0.5 standard deviation (SD) difference)*

4/5 = as above, but medium effect size (e.g. 0.5 - 0.8 SD difference)*


5/5 = as above, but large effect size (e.g. > 0.8 SD difference)*

effect size can be measured by cohens D or hedges G, basically its just how many standard deviations the therapy changed the outcome from the control group, this is a simple equation done in excel - see this video on cohens D https://www.youtube.com/watch?v=IetVSlrndpI&t=1s

* effect sizes must exceed a minimum clinically significant difference (MCSD) otherwise they are scored at 2/5... i.e. can have a large statistically significant standard deviation increase that reduces systolic blood pressure by 1 mmHg, which is clinically insignificant as the MCSD is 2 mmHg

rapidGRADE TEST ACCURACY

Diagnostic accuracy score out of 5

1/5 = animal data accuracy

2/5 = any non randomised peer reviewed human data


3/5 = over 0.7 correlation against gold standard index test (e.g. ROC curve score or R correlation coefficients) accuracy in randomised human data)


4/5 = over 0.8


5/5 = over 0.9

So whoop watch would score 5/5 for nighttime deep sleep 5 minute rMSSD HRV based on their radnomised diagnostic test accuracy peer reviewed study
 

but it would only score 4/5 for deep sleep
 

but 5/5 for REM sleep
 

whereas Oura ring would score 0/5 for WASO (wake after sleep onset)

rapidGRADE SAFETY

Safety score out of 5

For all data randomised controlled trial side effect data should be searched for systematically first, and then Phase 4 data and case reports, SIDER EMBL and pubmed Clinical Queries are good resources for RCT data; MHRA/FDA databases, iodine.com (USA VPN required), patients like me, any search in pubmed are good for case reports; normal Google, and Google Scholar or EMBASE/ CINAHL/ PSYCHINFO/ Chinese Databases is good for more extensive searching

1/5 = Only animal evidence of non-life long relevant animal model safety data

2/5 = Only animal safety evidence of: Near life long / full life long mammal animal safety data AND safety data in relevant 2D or ideally 3D human cell/tissue/organ models

2/5 = good evidence of common serious organ damage side effects (>2% rate) in humans, at any followup time

For the following: In similar dose range and route, of the exact same intervention as used in the studies, for a given age and disease condition population

3/5 = Good evidence of rare (<0.5% rate) or uncommon (0.5% - 2% rate), serious organ damage side effects (e.g. Yellow fever vaccine, rapamycin) at any time period of followup

4/5 = Good evidence of common (>2% rate), non-serious side effects (e.g. metformin slow release 500 mg - 1500 mg, nicotinamide riboside), at any time period of followup

5/5 = No good evidence of rare or common serious OR non-serious side effects for 2+ years followup with over 10,000 people taking the intervention (e.g. vitamin B12)

Note dose range and route are very important for assessing safety; as water has 5/5 safety at low doses... 0/5 safety at high doses or the wrong route of administration!

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