Table 2

Preliminary proposed recommendations for reference cases in each of three musculoskeletal disorders

Methodological issueOsteoporosisRheumatoid arthritisOsteoarthritis (NSAIDs)
1.Model horizonLifetimeOne yearLifetime
2.Duration of treatment

  • i. Typical for specific drug

  • ii. Ideal for specific drug

  • iii. 5 Years

ContinuousContinuous or intermittent use
3.Extrapolation beyond trial durationContinued effect size while receiving treatment adjusted by withdrawal rates from observational studiesEstimates of benefit based on trial data; estimates of withdrawal and long term outcomes based on observational dataContinued effect size whilst receiving treatment adjusted by withdrawal rates from observational studies
4.Modelling beyond trial durationLinear decline of effect size after treatment is continuedNo benefit or harm if treatment is stopped
5.Synthesis of comparisons where clinical trials do not existNot recommended owing to uncertain validity of transitive comparisons
6.Outcome measuresClinical fractures

  • ACR 20 sustained for 6 months

  • EULAR improvement criteria

  • Clinical adverse events

OARSI—20% improvement
Clinical adverse events
7.MortalityHazard for mortality from observational studiesIncorporate additional hazard attributable to drug based on observational data
8.Valuation of health (e.g. QALY)Values from general public for policy makers; values from patients for cliniciansValues from general population using direct measurementValues from general public for policymakers; values from patients for clinicians
9.Resource useInclude all associated direct medical costs in the analysis, but report indirect and non-medical costs separately
10.Classification and reporting of adverse eventsReport adverse events with patients as the unit of analysis using common toxicity criteria (under development by OMERACT Toxicity Working Group, Woodworth)
11.Discontinuation of treatmentUse discontinuation rates from observational studies
12.Therapeutic strategiesInclude modelling of most commonly used therapeutic strategy with sensitivity analysis to consider other strategies
13.Population risk stratificationInclude clear definition of underlying population including low and high risk groups