Thursday, July 04, 2013

Ten tips when writing about clinical trials by Ruth Francis, BioMed Central.

  1. Was this trial registered before it began? It should have been! So that we can scrutinise it and make sure negative results don’t get hidden.
  2. Is the primary outcome reported in the paper the same as the primary outcome specified in the protocol? If not, why not? Though researchers may publish their protocol in advance when registering a trial, not all registries require it.
  3. Look for other trials by this company, or group, or on this treatment and on registries: have these all been published? If not, then this report possibly represents a biased and cherry picked finding.
  4. ALWAYS mention who funded the trial – it matters. Whether some of the ethics committee people have some interest with the funding company.
  5. Look at whether the country where the work is done will benefit from the trial. Will they get the drug at a lower cost or not? Is it investing a disorder or disease that is a problem in that country.
  6. How many patients were on the trial, and how many were in each arm. Some trials can only have small patient groups, but others will need to study many more patients to draw the conclusions that may be being claimed.
  7. What was being compared? Was it drug vs placebo? Drug vs standard care? Drug with no control arm?
  8. Be precise about the sort of people or patients who benefited – was it just in advanced disease, people with a particular form of a disease? Contextualise how common these patients are in the bigger picture.
  9. Report natural frequencies as these are much more meaningful to both laypeople and experts: 13 people per 1000 experiencedis clearer than 1.3% of people experienced x
  10. Avoid relative risks and try to paint the findings in meaningful terms. So if you say the drug improved survival by X% it’s hard to know quite what that means. If you wrote: people taking the drug lived four months longer on average, you’d be clearer. Best of all would be to say: patients taking the drug lived four months longer on average, which is two months longer than the control group.

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