Contributions
Abstract: P904
Type: Poster
Abstract Category: Clinical aspects of MS - Clinical assessment tools
The present study represents a preliminary work of the Italian MS Spasticity Task Force, aimed at determining the direction and strength of the recommendations on the treatment of spasticity in Multiple Sclerosis (MS). We followed the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, which is based on a sequential assessment of the quality of evidence, followed by assessment of the balance between advantages and disadvantages, and finally judgement about the strength of recommendations. A panel of MS experts including clinicians and researchers and one MS patient identified nine clinical questions, and rated their importance based on relevance to patients for decision making. A literature search updated to 15th February 2016 was conducted for each of the interventions considered in the PICOquestions, looking for systematic reviews and randomized clinical trials and using MEDLINE, Embase and Scopus. For those interventions with inexisting or very few RCT available, the search was extended to observational studies. Those studies that fulfilled our inclusion criteria (population: MS patients with spasticity, intervention: those considered in the questions, comparator: any; outcome: any) were considered for the outcome evaluation process. A working group of the Task Force analyzed and graded the importance of the outcomes, based upon their relevance to spasticity, classified as unrelated, direct, indirect or as a global measure influenced by spasticity, and upon the level of validation of the measure, classified as full (level A), partial (level B), insufficient (R-rejected). Outcomes were classified as objective/instrumental measures (n=22), or requiring judgment by the assessing physician (57), or requiring judgment by the patient, i.e. patient reported outcome (n=40). Among the identified instrumental outcomes, 7 were judged as Class A direct measures, 4 among the physician subjective outcomes and 4 among the patient reported outcomes. Although ongoing work will determine the validity and relevance of treatment recommendations, these results suggest that outcome selection and standardization is recommended in the view of planning clinical trials for the treatment of spasticity, in order to allow comparability of results, performing meta-analysis and identify clinical and instrumental predictors of treatment response, towards treatment validation and individualization.
Disclosure: LL: received compensation for speaking/consultancy/research/travel support by: Biogen, Novartis, Genzyme, Merck, Almirall, Biogen, Excemed. None related to the present study.
Abstract: P904
Type: Poster
Abstract Category: Clinical aspects of MS - Clinical assessment tools
The present study represents a preliminary work of the Italian MS Spasticity Task Force, aimed at determining the direction and strength of the recommendations on the treatment of spasticity in Multiple Sclerosis (MS). We followed the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, which is based on a sequential assessment of the quality of evidence, followed by assessment of the balance between advantages and disadvantages, and finally judgement about the strength of recommendations. A panel of MS experts including clinicians and researchers and one MS patient identified nine clinical questions, and rated their importance based on relevance to patients for decision making. A literature search updated to 15th February 2016 was conducted for each of the interventions considered in the PICOquestions, looking for systematic reviews and randomized clinical trials and using MEDLINE, Embase and Scopus. For those interventions with inexisting or very few RCT available, the search was extended to observational studies. Those studies that fulfilled our inclusion criteria (population: MS patients with spasticity, intervention: those considered in the questions, comparator: any; outcome: any) were considered for the outcome evaluation process. A working group of the Task Force analyzed and graded the importance of the outcomes, based upon their relevance to spasticity, classified as unrelated, direct, indirect or as a global measure influenced by spasticity, and upon the level of validation of the measure, classified as full (level A), partial (level B), insufficient (R-rejected). Outcomes were classified as objective/instrumental measures (n=22), or requiring judgment by the assessing physician (57), or requiring judgment by the patient, i.e. patient reported outcome (n=40). Among the identified instrumental outcomes, 7 were judged as Class A direct measures, 4 among the physician subjective outcomes and 4 among the patient reported outcomes. Although ongoing work will determine the validity and relevance of treatment recommendations, these results suggest that outcome selection and standardization is recommended in the view of planning clinical trials for the treatment of spasticity, in order to allow comparability of results, performing meta-analysis and identify clinical and instrumental predictors of treatment response, towards treatment validation and individualization.
Disclosure: LL: received compensation for speaking/consultancy/research/travel support by: Biogen, Novartis, Genzyme, Merck, Almirall, Biogen, Excemed. None related to the present study.