Background
Methods – Fig. 1
Develop PICO questions
Systematic review
Quality of evidence
Level | Criteria |
Level 1 | Systematic review of randomized trials or n-of-1 trials |
Level 2 | Randomized trial or observational study with dramatic effect including crossover studies |
Level 3 | Non-randomized controlled cohort/follow-up study |
Level 4 | Case-series, case–control, or historically controlled studies |
Level 5 | Mechanism-based reasoning |
Level III | Sample is representative of the entire traumatic brain injury (TBI) population or the results are applicable to the entire TBI population |
Level II | Sample is representative of a relevant subgroup of the target TBI population (i.e., patients <1 year post-injury, patients <65 years of age, etc.) |
Level I | Sample is only representative of a narrow subgroup of the target TBI population and not well generalizable to other subgroups |
Good (low risk of bias) | These studies have the least bias and results are considered valid. A study that adheres mostly to the commonly held concepts of high quality including the following: a formal randomized controlled study; clear description of the population, setting, interventions, and comparison groups; appropriate measurement of outcomes; appropriate statistical and analytic methods and reporting; no reporting errors; low dropout rate; and clear reporting of dropouts. |
Fair | These studies are susceptible to some bias, but it is not sufficient to invalidate the results. They do not meet all the criteria required for a rating of good quality because they have some deficiencies, but no flaw is likely to cause major bias. The study may be missing information, making it difficult to assess limitations and potential problems. |
Poor (high risk of bias) | These studies have significant flaws that imply biases of various types that may invalidate the results. They have serious errors in design, analysis, or reporting; large amounts of missing information; or discrepancies in reporting. |
Delphi panel and making a recommendation
Results
Quality of evidence
GRADE strength | Strong | Weak/conditional | Exception | Weak/conditional | Strong |
Assessors’ view of the balance of desirable and undesirable consequences of the intervention | Desirable consequences clearly outweigh undesirable consequences | Desirable consequences probably outweigh undesirable consequences | Undesirable consequences probably outweigh desirable consequences | Undesirable consequences clearly outweigh desirable consequences | |
Recommendation | We recommend to “do something” | We suggest/conditionally recommend to “do something” | We suggest/conditionally recommend to “not do something” | We recommend to “not do something” |