Table 2.
Comparison of two approaches with a stepwise approach to clinical evaluation
| Phase | Complex intervention research (MRC) (10,11) | Phase | CAM systems research (NAFKAM) (13,14) |
|---|---|---|---|
| 0 | Theoretical (pre-clinical) phase; description (map) of elements from the literature | 1 | Describe clinical practice in widespread use |
| I | Modeling: understanding intervention and its possible effects | 2 | Assess safety in routine practice; data collection (quality, quantity) observational studies |
| II | Exploratory (pilot) trial(s): to assess feasibility and optimize design of main RCT | 3 | Assess the system effect (effectiveness of routine practice possibly using a pragmatic RCT) |
| III | ‘Definitive’ RCT (explanatory or pragmatic) | 4 | Assess specific component effect (efficacy) principle method: explanatory RCT |
| IV | Long-term implementation: assess long-term and real life effectiveness and potential adverse effects ((likely to be an observational study) | 5 | Assess mechanisms of action |
MRC, Medical Research Council, UK; NAFKAM, Nasjonalt Forskningssenter innen Komplementaer og Alternativ Medisin, Norway.