Definitions of the ratings of recommendation (A-C, U) and the classification of the evidence (Class I-IV) are provided at the end of the "Major Recommendations" field.
Based on this review, the Immunization Panel of the Multiple Sclerosis (MS) Council for Clinical Practice Guidelines recommends that:
- Patients with MS should follow Centers for Disease Control indications for immunizations (http://www.cdc.gov/vaccines/recs/schedules/adult-schedule.htm) (Influenza: Level A recommendation; hepatitis B, varicella, tetanus: Level C recommendation; other vaccines: Level U recommendation, expert opinion).
- Vaccination should be delayed during clinically significant relapses until patients have stabilized or have begun to improve from the relapse, typically 4 to 6 weeks after the start of the relapse. There is, however, no evidence regarding this practice (Level U recommendation, expert opinion). For patients who require tetanus vaccination after a wound, the panel recommends not to delay vaccination even if they are in a midst of a relapse, although, again, there is no actual evidence on this point (Level U recommendation, expert opinion).
- There is a divided opinion among experts regarding the potential usefulness of influenza vaccine in patients with MS who do not otherwise meet the Centers for Disease Control indications for vaccination. The panel recommends that potential risks and benefits of vaccination in these circumstances be discussed individually with each patient (Level U recommendation, expert opinion).
- Pneumococcal vaccine should be considered for patients with compromised pulmonary function, such as wheelchair-dependant or bed-bound patients. There is, however, no evidence regarding this practice (Level U recommendation, expert opinion).
Definitions:
Rating of Recommendation (technology assessment ratings in parentheses)
A = established as effective, ineffective or harmful (or established as useful/predictive or not useful/predictive) for the given condition in the specified population
B = probably effective, ineffective or harmful (or probably useful/predictive or not useful/predictive) for the given condition in the specified population
C = possibly effective, ineffective or harmful (or possibly useful/predictive or not useful/predictive) for the given condition in the specified population
U = data inadequate or conflicting. Given current knowledge, treatment (test, predictor) is unproven.
Rating of Therapeutic Article
Class I: Prospective, randomized, controlled clinical trial with masked outcome assessment, in a representative population.
The following are required:
- Primary outcome(s) is/are clearly defined.
- Exclusion/inclusion criteria are clearly defined.
- Adequate accounting for dropouts and crossovers with numbers sufficiently low to have minimal potential for bias.
- Relevant baseline characteristics are presented and substantially equivalent among treatment groups or there is appropriate statistical adjustment for differences.
Class II: Prospective matched group cohort study in a representative population with masked outcome assessment that meets a-d above OR a randomized, controlled clinical trial in a representative population that lacks one criterion a-d.
Class III: All other controlled trials (including well-defined natural history controls or patients serving as own controls) in a representative population, where outcome assessment is independent of patient treatment.
Class IV: Evidence from uncontrolled studies, case series, case reports, or expert opinion.
Rating of Prognostic Article
Class I: Evidence provided by a prospective study of a broad spectrum of persons who may be at risk for developing the outcome (e.g., target disease, work status). The study measures the predictive ability using an independent gold standard for case definition. The predictor is measured in an evaluation that is masked to clinical presentation and the outcome is measured in an evaluation that is masked to the presence of the predictor.
Class II: Evidence provided by a prospective study of a narrow spectrum of persons at risk for having the condition, or by a retrospective study of a broad spectrum of persons with the condition compared to a broad spectrum of controls. The study measures the prognostic accuracy of the risk factor using an acceptable independent gold standard for case definition. The risk factor is measured in an evaluation that is masked to the outcome.
Class III: Evidence provided by a retrospective study where either the persons with the condition or the controls are of a narrow spectrum. The study measures the predictive ability using an acceptable independent gold standard for case definition. The risk factor is measured in an evaluation that is masked to the outcome.
Class IV: Any design where the predictor is not applied in a masked evaluation OR evidence provided by expert opinion or case series without controls.
