Policy vs Evidence: A Case Study
Tom Jefferson’s paper1 is welcome if it leads policy-makers to
acknowledge evidence being more than a non-essential afterthought to their
policy-making. The NHS R&D HTA programme undertook an RCT evaluating the
extension of routine influenza immunization to the healthy elderly2,3.
The study was undertaken in a primary care setting and adequately powered
given the anticipated efficacy of the vaccine. A diary system was
employed to capture all episodes of influenza-like illness irrespective of
whether they led to contact with the health services. Quality of life was
evaluated at 2, 4 and 6 months and adverse reactions were analysed to
assess possible side-effects. Finally, an impact model was used to assess
the generalisability of results throughout the NHS.
In short, this trial generated exactly the type of robust and high
quality evidence required to inform national policy-making. Unfortunately,
while our study was still in progress, new guidelines were introduced that
extended routine vaccination to all people over 65. In such
circumstances, we had no option but to stop randomising patients to
placebo as we felt that this could disadvantage them in comparison to
routine clinical care. In effect, our attempt to gain evidence had been
obviated by extending vaccination to precisely the patient group that we
were in the process of evaluating. Because of this, the quality of
evidence that we were able to generate was severely constrained. However,
even with this limited evidence base, we questioned the potential benefits
and cost savings associated with extending vaccination to the healthy
elderly as it compared poorly with standards applied in recent NICE
guidelines and introduced the danger of the worried well ‘crowding out’
patients in whom vaccination would provide greater clinical benefits. The
existing gap between policy and evidence will remain until evidence-based
policy-making supplants political expediency in the NHS.
1 Jefferson T. Influenza vaccination: policy versus evidence. BMJ
2006; 333: pp912-915.
2 Allsup S, Haycox A, Regan M, Gosney M. Is influenza vaccination
cost effective for healthy people between ages 65 and 74 years? A
randomised controlled trial. Vaccine 2004; 23: pp639-645.
3 Allsup S, Gosney M, Haycox A, Regan M. Cost-benefit evaluation of
routine influenza immunisation in people 65-74 years of age. Health
Technology Assessment NHS R&D HTA Programme 2003; Vol 7: No 24.
Competing interests: No competing interests