Proposed Outcomes

CMSG review authors are strongly recommended to consult the following list of proposed outcomes for their summary of findings.

Ankylosing spondylitis:

  • ASAS partial remission

  • BASFI

  • ASAS 40

  • MRI

  • Serious adverse events

  • Withdrawals due to adverse events

  • Radiographic progression

Rheumatoid arthritis:

  • ACR 50

  • DAS (low)

  • HAQ for function

  • X-ray or appropriate imaging changes

  • Short term serious adverse effects from trials

  • Long term adverse effects or toxicity from observational studies

  • Withdrawals due to adverse events

 

 Juvenile Idiopathic Arthritis (JIA):

    • Composite measure of disease activity (e.g., clinical Juvenile Arthritis Disease Activity Score (JADAS), systemic JADAS, American College of Rheumatology (ACR) 30/50/70/90 response, other)
    • Clinically inactive disease / remission (e.g., Wallace criteria, JADAS criteria, other)
    • Activity limitation / physical function (e.g., Childhood Health Assessment Questionnaire (CHAQ), other)
    • Pain (e.g., visual analogue scale, faces pain scale, other)
    • Patient perception of disease activity / overall wellbeing (e.g., patient or parent/carer global assessment of disease activity, other)
    • Serious AEs including death
    • Withdrawal due to AEs

     

    Osteoarthritis:

    1. Pain with a hierarchy of 11 levels (when more than one is reported, take the highest on the list):

    • Pain overall

    • Pain on walking

    • WOMAC pain subscale

    • Pain on activities other than walking

    • WOMAC global scale

    • Lequesne osteoarthritis index global score

    • Other algofunctional scale

    • Patient’s global assessment

    • Physician’s global assessment

    • Other outcome

    • No continuous outcome reported

    2. Physical function with a hierarchy of eight levels (when more than one is reported, take the highest on the list):

    • Global disability score

    • Walking disability

    • WOMAC disability subscore

    • Composite disability scores other than WOMAC

    • Disability other than walking

    • WOMAC global scale

    • Lequesne osteoarthritis index global score

    • Other algofunctional scale 

     3. Radiographic joint structure changes according to the given hierarchy (the first two outcomes, minimum joint space width and median joint space width, are mostly used):

    • Minimum joint-space width

    • Median joint-space width

    • Semi-quantitative measurement

      4.  Quality of Life

     5.   Short term serious adverse effects from trials

     6.　Long term adverse effects or toxicity from observational studies

     7.　Withdrawals due to adverse events

    Fibromyalgia

    • Pain (e.g., visual analogue scale [VAS] or 10-point ordinal scale)

    • Global well-being (overall feeling of well-being) or perceived improvement in FM symptoms (outcomes such as the Fibromyalgia Impact Questionnaire [FIQ] total score, study participant-rated change in FM symptoms, observer-rated change in FM symptoms). (Note: The FIQ is a self-report questionnaire developed to evaluate overall impact of FM. The individual with FM rates commonly experienced FM symptoms, including [but not restricted to] pain, fatigue, depression, anxiety, level of restedness after sleep, and effect of FM on work. The scores for each item can be reported individually or summed to report the FIQ total score.)

    • Physical function

    • Self report or physical performance measure

    • Tender points (e.g., pain threshold of tender points using dolorimetry or tenderness to thumb pressure)

    • QoL, Mental Health

    • Depression (e.g., Beck Depression Inventory, FIQ subscale for depression)

    • Serious adverse events

    • Withdrawals due to adverse events

    Lupus

    • Disease activity measured using a disease activity composite index or response criteria, e.g. Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; SLEDAI-2K), the Systemic Lupus Erythematosus Disease Activity Index SELENA Modification (SELENA-SLEDAI), modified SELENA-SLEDAI Flare Index (SFI), British Isles lupus assessment group index (BILAG; BILAG 2004), SLE Responder Index (SRI), BILAG-Based Composite Lupus Assessment (BICLA)
    • Damage accrual, as assessed using a damage activity score, eg. Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index (SDI)
    • Steroid requirements; e.g. by reduction in glucocorticoid dose, defined as mean reduction of prednisone equivalent dose in mg/day, cumulative dose, % reduction or below a certain threshold (< 10 mg/day or < 7.5 mg/day), or % patients off glucocorticoids; or steroid equivalent, defined by converting all steroid doses to daily prednisone equivalents.
    • Quality of life assessed by instruments such as the Short-Form 36 (SF-36), EQ-5D, LupusQoL, SLEQoL, or similar assessments.
    • Withdrawals due to adverse events or serious infections [review team should decide depending on the intervention]
    • Serious adverse events (SAEs), defined as those requiring hospitalization or resulting in death
    • Death


    Osteoporosis

    • Clinical vertebral fractures
    • Non-vertebral fractures
    • Hip fractures
    • Wrist fractures
    • Withdrawals due to adverse events
    • Serious adverse events

    Surgical joint replacement

    • Survival rate of the implant (any change of a component)

    • Health-related quality of life measures and functional measures with validated instruments (WOMAC, KOOS, OXFORD, IKDC, DASH, etc.)

    • Pain

    • Performance-based measures (if validated)

    • Global assessment (patient)

    • Total adverse event (infection, thrombosis, palsy, death, etc.)

    • Re-operation rate (not involving implant change, short- and long-term)