Abstract
Background
Although randomized control trials (RCTs) are the ‘gold standard’ to evaluate treatment effects in health care, they are frequently not practical, ethical or politically acceptable in the evaluation of many health system or public health interventions. A good example where a health system intervention has undergone evaluation using an RCT design is the universal health insurance scheme, Seguro Popular, in Mexico.1 However, this is a rare exception mainly due to the academic background of the Mexican Health Minister, Julio Frenk, who introduced the scheme. More frequently, randomization is not feasible or practical, particularly when interventions target whole or large subgroups of populations. Because of political considerations, policy makers often want to implement changes quickly and refuse to wait several years to determine a new intervention's effects. Further, they may be reluctant to be seen to withhold an intervention from a particular community, as was the case with the SureStart programme,2 which aimed to improve health and educational outcomes in young children in the UK. RCTs may also be unethical where clear evidence of benefit has been demonstrated from observational studies, as was the case with cervical cancer screening. Additionally, lack of funding often poses a hurdle to formal evaluation through an RCT, as RCTs can be very costly to carry out.
Although randomized control trials (RCTs) are the ‘gold standard’ to evaluate treatment effects in health care, they are frequently not practical, ethical or politically acceptable in the evaluation of many health system or public health interventions. A good example where a health system intervention has undergone evaluation using an RCT design is the universal health insurance scheme, Seguro Popular, in Mexico.1 However, this is a rare exception mainly due to the academic background of the Mexican Health Minister, Julio Frenk, who introduced the scheme. More frequently, randomization is not feasible or practical, particularly when interventions target whole or large subgroups of populations. Because of political considerations, policy makers often want to implement changes quickly and refuse to wait several years to determine a new intervention's effects. Further, they may be reluctant to be seen to withhold an intervention from a particular community, as was the case with the SureStart programme,2 which aimed to improve health and educational outcomes in young children in the UK. RCTs may also be unethical where clear evidence of benefit has been demonstrated from observational studies, as was the case with cervical cancer screening. Additionally, lack of funding often poses a hurdle to formal evaluation through an RCT, as RCTs can be very costly to carry out.
| Original language | Undefined/Unknown |
|---|---|
| Pages (from-to) | 124–129 |
| Journal | Journal of the Royal Society of Medicine |
| Volume | 106 |
| Issue number | 4 |
| Early online date | 1 Apr 2013 |
| DOIs | |
| Publication status | Published - 1 Apr 2013 |