A post-trial survey to assess the impact of dissemination of results and unmasking on participants in a 13-year randomised controlled trial on age-related cataract
2011

Impact of Sharing Trial Results on Participants in a Cataract Study

Sample size: 817 publication 10 minutes Evidence: moderate

Author Information

Author(s): Sally L Williams, Luigina Ferrigno, Giovanni Maraini, Francesco Rosmini, Robert D Sperduto

Primary Institution: Università degli Studi di Parma

Hypothesis

How does sharing trial results affect participants' understanding and satisfaction?

Conclusion

Most participants were satisfied with the results shared, but nearly 20% expressed some concern.

Supporting Evidence

  • 94.6% of participants found the results clear.
  • 89.8% found the results interesting.
  • 60.3% expressed satisfaction with the results.
  • 78.7% accepted the offer to learn their treatment assignment.

Takeaway

The study asked older people about their feelings after learning the results of a cataract treatment trial, and most were happy but some were worried.

Methodology

Participants completed questionnaires to assess their satisfaction and understanding of the trial results.

Potential Biases

Potential selection bias from participants who declined to know their treatment assignment.

Limitations

The study may have biases due to non-responders being older and less educated.

Participant Demographics

Participants were elderly, aged 55 to 75, with a mean age of 80.5 years.

Statistical Information

P-Value

p = 0.0006

Confidence Interval

0.60 - 1.02

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1186/1745-6215-12-148

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