Intended for healthcare professionals


Receiving a summary of the results of a trial: qualitative study of participants' views

BMJ 2006; 332 doi: (Published 26 January 2006) Cite this as: BMJ 2006;332:206
  1. Mary Dixon-Woods, senior lecturer in social science and health (md11{at},
  2. Clare Jackson, research associate1,
  3. Kate C Windridge, research fellow2,
  4. Sara Kenyon, senior research fellow3
  1. 1 Social Science Group, Department of Health Sciences, University of Leicester, Leicester LE1 6TP
  2. 2 Trent Research and Development Support Unit, Department of Health Sciences
  3. 3 MRC Oracle Children's Study, Reproductive Sciences Section, Department of Cancer and Molecular Studies, University of Leicester, Leicester LE2 7LX
  1. Correspondence to: M Dixon-Woods
  • Accepted 8 November 2005


Objective To explore trial participants' responses to receiving a summary of the results of a trial in pregnancy.

Design Qualitative study with semistructured interviews.

Participants 20 women who had when pregnant participated in the ORACLE trial of antibiotics for preterm labour and preterm rupture of the membranes and requested a copy of the trial results.

Results Less than a fifth of women who participated in the ORACLE trial indicated that they wished to receive the trial results. Reactions to the leaflet summarising the trial results were generally positive or neutral, although some women had difficulty in understanding the leaflet, and there was evidence of possible negative implications for women who had adverse outcomes. Women requested the results because they were interested in being able to complete their own personal narrative. They wished to know to which arm of the trial they had been allocated and the implications for their own pregnancy, and they were disappointed with receiving a generic summary. Women's accounts indicated some confusion about the trial findings.

Conclusions Recommendations that research participants be routinely provided with the results of studies have been made without the benefit of research to show the consequences of doing this or how it should best be managed. Caution is needed, as is more evaluation of how feedback of results should be handled, and assessment of the risks, benefits, and costs.


  • Contributors SK and MDW were responsible for concept and design. KCW was responsible for data collection. MDW, SK, and CJ were responsible for data analysis. MDW and CJ wrote the first draft of the paper. All authors interpreted the data, helped in the preparation of the manuscript, and approved the paper. MDW is the guarantor.

  • Funding This study was funded by the UK Medical Research Council as part of the MRC Oracle trial.

  • Competing interests SK was an investigator on the MRC ORACLE trial Ethical approval: North West Multicentre Research Ethics Committee.

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