David Baxter PhD
Late Founder
When and how should new therapies become routine clinical practice?
by Kari B?, Norwegian School of Sport Sciences, Oslo, Norway
and Robert D. Herbert, George Institute for International Health, Camperdown, NSW 2050, Australia
January 2009
Abstract
The process by which new therapies enter clinical practice is frequently suboptimal. Often, ideas for new therapies are generated by clinical observations or laboratory studies; therapies based on those ideas may enter clinical practice without any further scrutiny. As a consequence, some ineffective practices become widespread. This article proposes a six-stage protocol for the implementation of new therapies. Hypotheses about therapy based on preclinical research should be subject to clinical exploration and pilot studies prior to rigorous assessment with randomised clinical trials. If randomised clinical trials suggest that the intervention produces clinically important effects, further randomised studies can be conducted to refine the intervention. New interventions should not be recommended, or included in teaching curricula, or taught in continuing education courses until their effectiveness has been demonstrated in high-quality randomised clinical trials.
Article Outline
by Kari B?, Norwegian School of Sport Sciences, Oslo, Norway
and Robert D. Herbert, George Institute for International Health, Camperdown, NSW 2050, Australia
January 2009
Abstract
The process by which new therapies enter clinical practice is frequently suboptimal. Often, ideas for new therapies are generated by clinical observations or laboratory studies; therapies based on those ideas may enter clinical practice without any further scrutiny. As a consequence, some ineffective practices become widespread. This article proposes a six-stage protocol for the implementation of new therapies. Hypotheses about therapy based on preclinical research should be subject to clinical exploration and pilot studies prior to rigorous assessment with randomised clinical trials. If randomised clinical trials suggest that the intervention produces clinically important effects, further randomised studies can be conducted to refine the intervention. New interventions should not be recommended, or included in teaching curricula, or taught in continuing education courses until their effectiveness has been demonstrated in high-quality randomised clinical trials.
Article Outline
- Introduction
- The life cycle of a medical innovation
- Stage 1. The promising report
- Stage 2. Professional adoption
- Stage 3. Public acceptance
- Stage 4. Standard practice
- Stage 5. Randomised clinical trials
- Stage 6. Professional denunciation
- Stage 7. Extinction
- A case study: deep abdominal muscle training for stress urinary incontinence
- What drives choices about implementation of new therapies?
- Clinical experience
- Theories based on preclinical research
- Randomised clinical trials
- Proposal for a protocol for introduction of new therapies
- Stage 1. Clinical observation or laboratory studies
- Stage 2. Clinical exploration
- Stage 3. Pilot studies
- Stage 4. Randomised clinical trials and systematic reviews
- Stage 5. Refinement
- Stage 6. Active dissemination
- Anticipation of some objections
- Conclusions
- References
