Imacs Core Set Measures
Laurelino Braendel
The site is secure.
The ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.
Disease activity assesses the manifestations of myositis which are thought to be reversible that result directly from the inflammatory process. IMACS has developed a consensus on a set of Core Set Domains and Measures for the assessment of disease activity. IMACS recommends these core set measures be included in all myositis therapeutic trials and clinical studies that assess disease activity in patients with myositis. The core set myositis disease activity measures are described below. Tools and additional educational resources are available to IMACS members. Please log in to view this material.
Some of the tools are under copyright, and require specific citation when used in publications. The excel file here provides a listing of all of the tools, authors and publishers. Additional permissions are often required, and we request you check with authors and the journals for permission to use specific tools.
This partially validated tool measures the global evaluation by the treating physician of the overall disease activity of the patient at the time of assessment using a 10 cm. visual analogue scale and a 5 point Likert scale.
This partially validated tool measures the global evaluation by the patient, or by the parent if the patient is a minor, of the patient's overall disease activity at the time of assessment using a 10 cm. visual analogue scale.
This partially validated tool assesses muscle strength using manual muscle testing (MMT). A 0 - 10 point scale is proposed for use. An abbreviated group of 8 proximal, distal, and axial muscles performs similarly to a total of 24 muscle groups, and is also proposed for use for research studies.
These are three partially validated tools to assess physical function. The Health Assessment Questionnaire (HAQ) Disability Index is to be used for adults and the Childhood HAQ (CHAQ) in children. The Childhood Myositis Assessment Score (CMAS) has been validated in children with myositis. IMACS recommends the use of at least one of these tools to assess physical function as a core set measure in therapeutic trials and clinical studies reporting on myositis disease activity.
This partially validated tool measures the serum activities of at least 2 of the 4 muscle-associated enzymes including creatine phosphokinase (CK), the transaminases (ALT, AST), lactate dehydrogenase (LD) and aldolase.
This validated tool measures the degree of disease activity of extra-muscular organ systems and muscle. This is a combined tool that includes the MYOSITIS DISEASE ACTIVITY ASSESSMENT VISUAL ANALOGUE SCALES (MYOACT), which is a series of physician's assessments of disease activity of various organ systems modified from the Vasculitis Activity Index (QE Whiting-O'Keefe et al. 1999, Arthritis and Rheumatism 42: 2365-71), and the MYOSITIS INTENTION TO TREAT ACTIVITY INDEX (MITAX), which is modified from the BILAG approach to assess disease activity in lupus (EM Hay et al., 1993, Q J Medicine, 86: 447-58). The MITAX is composed of a series of organ-specific questions relating to the presence or absence of the clinical feature and the degree of treatment needed for it (intention to treat).
The Myositis Disease Activity Assessment Tool (MDAAT) has undergone inter-rater reliability testing in adult and juvenile myositis patients in workshops led by Professor David Isenberg and Dr. Clarissa Pilkington. The MITAX is scored on a 0 - 4 scale, based on worsening or improvement in specific clinical features and their correlation with the intention to treat. The tool has undergone a major international reliability and validity exercise in six adult myositis centers, in order to validate the instrument based on the correlation with the intention to treat (references and unpublished data). The version posted here is based on the results of these studies and is the current version recommended for use in prospective trials and clinical studies. This will be the version available in the IMACS Outcomes Repository.
Objectives: Sporadic inclusion body myositis (IBM) is a debilitating idiopathic inflammatory myopathy (IIM) which affects hand function, ambulation, and swallowing. There is no approved pharmacological therapy for IBM, and there is a lack of suitable outcome measure to assess the effect of an intervention. The IBM scientific interest group under IMACS reviewed the previously used outcome measures in IBM clinical studies to lay the path for developing a core set of outcome measures in IBM.
Methods: In this systematised review, we have extracted all outcome measures reported in IBM clinical studies to determine what measures were being used and to assess the need for optimising outcome measures in IBM.
Results: We found 13 observational studies, 17 open-label clinical trials, and 15 randomised control trials (RCTs) in IBM. Six-minute walk distance, IBM-functional rating scale (IBM-FRS), quantitative muscle testing, manual muscle testing, maximal voluntary isometric contraction testing, and thigh muscle volume measured by MRI were used as primary outcome measures. Twelve different outcome measures of motor function were used in IBM clinical trials. IBM-FRS was the most used measure of functionality. Swallowing function was reported as a secondary outcome measure in only 3 RCTs.
Conclusions: There are inconsistencies in using outcome measures in clinical studies in IBM. The core set measures developed by the IMACS group for other IIMs are not directly applicable to IBM. As a result, there is an unmet need for an IBM-specific core set of measures to facilitate the evaluation of new potential therapeutics for IBM.
There is a great demand today for accurate, useful information on health care quality that can inform the decisions of consumers, employers, clinicians, and policymakers. This is increasingly important as the health care system moves towards value-based reimbursement models.
It is difficult to have actionable and useful information because clinicians must currently report multiple quality measures to different entities. Measure requirements are often not aligned among payers, which has resulted in confusion and complexity for reporting health care providers.
To address this problem, CMS, commercial plans, Medicare and Medicaid managed care plans, purchasers, clinicians and other care provider organizations, and consumers worked together through the CQMC to identify core sets of quality measures that payers have committed to using for reporting as soon as feasible. The guiding principles used by the CQMC in developing the core measure sets are that they be meaningful to patients, consumers, and clinicians, while reducing variability in measure selection, collection burden, and cost. The goal is to establish broadly agreed upon core measure sets that could be harmonized across both commercial and government payers.
Using a multi-stakeholder, consensus-driven process, the CQMC, led by AHIP and its member plans, Chief Medical Officers, leaders from CMS, as well as national physician organizations, employers, and consumers, recommend core performance measure sets that promote alignment and harmonization of measure use and collection across payers in both the public and private sectors.
To develop the core measure sets, the CQMC is split into workgroups and reviews measures currently in use by CMS and health plans as well as measures endorsed by the CBE for the individual measure sets. Based on this review and discussion, the workgroups identified a consensus core set for the selected clinical areas. This consensus core set was further discussed by all CQMC members before being finalized. Additionally, the CQMC developed a framework of aims and principles that informed the selection of core measure sets.
CMS is already using measures from each of the core sets. Using the notice and public comment rulemaking process, CMS also intends to implement new core measures across applicable Medicare and Medicaid quality programs as appropriate, while eliminating redundant measures that are not part of the core set. Commercial health plans are rolling out the core measures as part of their contract cycle.
Ongoing monitoring by the CQMC of the use of these measures will enable modifications of measure sets, as needed, and based on lessons learned, including minimizing unintended consequences and selection of new measures as better measures become available.
Objective: To investigate the potential associations between functional capacity, muscle strength, body composition, and disease-related measures and quality of life in patients with myositis. Methods: Baseline measures of functional capacity (functional index 3 (FI3), 2-minute walk test (2MWT), timed up and go (TUG) and 30-s sit-to-stand (30-STS)), muscle strength (incl. leg and handgrip strength), maximal leg extensor power, body composition (appendicular lean mass, fat percentage/mass) and disease-related measures (disease activity & damage core sets) were examined for their associations with quality of life (physical- and mental component summary scores, Short Form 36 questionnaire (SF-36)) by means of Spearman's correlation analysis. Results: A total of 32 patients with myositis were included. Positive correlations between SF-36 physical component summary score (PCS) and FI3, 30-STS, TUG, 2MWT, leg extensor power, leg strength, bench press strength, and handgrip strength were observed. In contrast, fat percentage and fat mass correlated negatively with PCS. In disease-related measures, Extramuscular global assessment, health assessment questionnaire, physician global damage, and patient global damage scores were negatively associated with SF-36 PCS. No correlations to the mental component summary score of SF-36 were observed. Conclusion: All measures of functional capacity were positively related to the SF-36 physical component summary score, indicating higher functional capacity positively affects quality of life in patients with myositis. Health assessment questionnaire and patient global damage scores demonstrated the strongest correlations with SF-36 physical component summary scores, further supporting these patient-reported outcomes as viable monitoring tools in patients with myositis.
c80f0f1006