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01.12.2017 | Research | Ausgabe 1/2017 Open Access

Trials 1/2017

Clinicians’ views and experiences of offering two alternative consent pathways for participation in a preterm intrapartum trial: a qualitative study

Zeitschrift:
Trials > Ausgabe 1/2017
Autoren:
Celine Y. Chhoa, Alexandra Sawyer, Susan Ayers, Angela Pushpa-Rajah, Lelia Duley
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​s13063-017-1940-5) contains supplementary material, which is available to authorized users.

Abstract

Background

The Cord Pilot Trial compared alternative policies for timing of cord clamping at very preterm birth at eight UK hospitals. Preterm birth can be rapid and unexpected, allowing little time for the usual consent process. Therefore, in addition to the usual procedure for written consent, a two-stage pathway for consent for use when birth was imminent was developed. The aims of this study were to explore clinicians’ views and experiences of offering two consent pathways for recruitment to a randomised trial of timing of cord clamping at very preterm birth.

Methods

This was a qualitative study using semi-structured interviews. Clinicians from eight hospitals in the UK who had been involved in offering consent to the Cord Pilot Trial were invited to take part in an interview. Clinicians were interviewed in person or by telephone. Interviews were analysed using inductive systematic thematic analysis.

Results

Seventeen clinicians who had either offered usual written consent only (n = 6) or both the two-stage pathway (with oral assent before the birth and written consent after the birth) and usual written consent (n = 11) were interviewed. Six themes were identified: (1) team approach to offering participation; (2) consent form as a record; (3) consent and participation as a continual process; (4) different consent pathways for different trials; (5) balance between time, information, and understanding; and (6) validity of consent. Overall, clinicians were supportive of the two-stage consent pathway. Some clinicians felt that in time-critical situations oral assent presented an advantage over the usual written consent as they provided information on a “need to know” basis. However, there was some concern about how much information should be given for oral assent, and how this is understood by women when birth is imminent.

Conclusions

The two-stage pathway for consent developed for use in the Cord Pilot Trial when birth was imminent was acceptable to clinicians for comparable low-risk studies, although some concerns were raised about the practicalities of obtaining oral assent.

Trial registration

ISRCTN Registry, ISRCTN21456601. Registered on 28 February 2013.
Zusatzmaterial
Additional file 1: Interview schedule (DOC 33 kb)
13063_2017_1940_MOESM1_ESM.doc
Additional file 2: Reporting guidelines for qualitative studies (DOCX 15 kb)
13063_2017_1940_MOESM2_ESM.docx
Literatur
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