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. 2014 Feb 28;2014:1211.

Table.

GRADE Evaluation of interventions for Dystonia.

Important outcomes Neurological disability, Quality of life
Studies (Participants) Outcome Comparison Type of evidence Quality Consistency Directness Effect size GRADE Comment
What are the effects of drug treatments for focal dystonia?
at least 14 (at least 1029) Neurological disability Botulinum A toxin versus placebo in cervical dystonia in adults 4 0 0 –1 0 Moderate Directness point deducted for including only people who had previously responded to onabotulinumtoxinA in 1 RCT
3 (308) Neurological disability Botulinum B toxin versus placebo in cervical dystonia in adults 4 0 0 0 0 High
3 (252) Neurological disability Botulinum A toxin versus botulinum B toxin in cervical dystonia in adults 4 0 0 –2 0 Low Directness points deducted for not reporting doses in 1 study and population differences between studies in previous experience with botulinum A toxin
1 (31) Neurological disability Low-dose (100 U Botox/250 U Dysport) versus high-dose (>200 U Botox/960 U Dysport) botulinum A toxin in cervical dystonia in adults 4 –2 0 –1 0 Very low Quality points deducted for sparse data and incomplete reporting of results; directness point deducted for no direct comparison between groups
1 (92) Neurological disability Low-dose (2500–5000 U) versus high-dose (10,000 U) botulinum B toxin in cervical dystonia in adults 4 –1 –1 0 0 Low Quality point deducted for sparse data; consistency point deducted for differing results with different outcome measures
1 (66) Neurological disability Botulinum A toxin versus trihexyphenidyl in cervical dystonia in adults 4 –2 0 –2 0 Very low Quality points deducted for sparse data and incomplete reporting; directness points deducted for differences in disease severity between groups and short cycle intervals between injections affecting generalisability of results
1 (92) Neurological disability Botulinum B toxin in botulinum A toxin-resistant adults versus respondent adults 4 –2 0 0 0 Low Quality points deducted for sparse data and incomplete reporting of results
1 (40) Neurological disability Botulinum A toxin versus placebo in people with writer's cramp 4 –1 –1 0 0 Low Quality point deducted for sparse data; consistency point deducted for differing results with different outcome measures
What are the effects of physical treatments for focal dystonia?
1 (40) Neurological disability Physiotherapy plus biofeedback plus drug treatment versus drug treatment alone 4 –2 0 –1 0 Very low Quality points deducted for sparse data, results after crossover, and unequal observation periods; directness point deducted for including only people who had previously responded to botulinum A toxin
1 (20) Neurological disability Physiotherapy plus relaxation versus no physiotherapy plus relaxation 4 –1 0 –1 0 Low Quality point deducted for sparse data; directness point deducted for including a subset of participants who were also receiving botulinum toxin
1 (20) Quality of life Physiotherapy plus relaxation versus no physiotherapy plus relaxation 4 –1 0 –1 0 Low Quality point deducted for sparse data; directness point deducted for including a subset of participants who were also receiving botulinum toxin
1 (31) Quality of life Voice therapy plus botulinum A toxin versus sham voice therapy plus botulinum A toxin versus botulinum A toxin-only for laryngeal dystonia (adductor spasmodic dysphonia) 4 –3 0 0 0 Very low Quality points deducted for sparse data, incomplete reporting of results, selection bias, and botulinum toxin dose inconsistencies
What are the effects of surgical treatments for generalised dystonia?
1 (40) Neurological disability Deep brain stimulation versus sham treatment 4 –2 0 –1 0 Very low Quality points deducted for sparse data and no long-term results; directness point deducted for inclusion of mixed population of people with focal and generalised dystonia
1 (less than 40) Quality of life Deep brain stimulation versus sham treatment 4 –2 –1 –1 0 Very low Quality points deducted for sparse data and no long-term results; consistency point deducted for lack of consistent benefit in different elements of quality of life; directness point deducted for inclusion of people with focal dystonia, affecting generalisability of results

We initially allocate 4 points to evidence from RCTs, and 2 points to evidence from observational studies. To attain the final GRADE score for a given comparison, points are deducted or added from this initial score based on preset criteria relating to the categories of quality, directness, consistency, and effect size. Quality: based on issues affecting methodological rigour (e.g., incomplete reporting of results, quasi-randomisation, sparse data [<200 people in the analysis]). Consistency: based on similarity of results across studies. Directness: based on generalisability of population or outcomes. Effect size: based on magnitude of effect as measured by statistics such as relative risk, odds ratio, or hazard ratio.