Influence of the statistical significance of results and spin on readers' interpretation of the results in an abstract for a hypothetical clinical trial: a randomised trial.

OBJECTIVES

To assess the impact on readers' interpretation of the results reported in an abstract for a hypothetical clinical trial with (1) a statistically significant result (SSR), (2) spin, (3) both an SSR and spin compared with (4) no spin and no SSR.

PARTICIPANTS

Health students and professionals from universities and health institutions in France and the UK.

INTERVENTIONS

Participants completed an online questionnaire using Likert scales and free text, after reading one of the four versions of an abstract about a hypothetical randomised trial evaluating 'Naranex' and 'Bulofil' (two hypothetical drugs) for chronic low back pain. The abstracts differed in (1) reported result of 'mean difference of 1.31 points (95% CI 0.08 to 2.54, p= 0.04)' or 'mean difference of 1.31 points (95% CI -0.08 to 2.70, p= 0.06)' and (2) presence or absence of spin. The effect size for the trial's primary outcome (pain disability score) was the same in each abstract, slightly in favour of Naranex.

PRIMARY OUTCOME

The reader's interpretation of the trial's results, based on their answer (1, disagree; 4, neutral; 7, agree) to the following statement: 'About the main findings of the study, what is your opinion about the following statement: 'Naranex is better than Bulofil'?'

RESULTS

Two hundred and ninety-seven of the 404 people randomised to receive one of the four abstracts completed the study. Respondents were more likely to favour Narenex when the abstract reported an SSR without spin, a statistically significant result with spin, a non-statistically significant result with spin, compared with when it reported a non-SSR without spin.

CONCLUSION

Statistical significance appears to have influenced readers' perception whatever the level of spin, while spin influenced readers' perception when the results were not statistically significant but did not appear to have an impact when results were statistically significant.