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Published in: Trials 1/2016

Open Access 01-12-2016 | Research

Recruiting and consenting into a peripartum trial in an emergency setting: a qualitative study of the experiences and views of women and healthcare professionals

Authors: Julia Lawton, Claire Snowdon, Susan Morrow, Jane E. Norman, Fiona C. Denison, Nina Hallowell

Published in: Trials | Issue 1/2016

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Abstract

Background

Recruiting and consenting women to peripartum trials can be challenging as the women concerned may be anxious, in pain, and exhausted; there may also be limited time for discussion and decision-making to occur. To address these potential difficulties, we undertook a qualitative evaluation of the internal pilot of a trial (Got-it) involving women who had a retained placenta (RP). We explored the experiences and views of women and staff about the information and consent pathway used within the pilot, in order to provide recommendations for use in future peripartum trials involving recruitment in emergency situations.

Methods

In-depth interviews were undertaken with staff (n = 27) and participating women (n = 22). Interviews were analysed thematically. The accounts of women and staff were compared to identify differences and similarities in their views about recruitment and consent procedures.

Results

Women and staff regarded recruitment as having been straightforward and facilitated by the use of simplified (verbal and written) summaries of trial information. Both parties, however, conveyed discordant views about whether fully informed consent had been obtained. These differences in perspectives appeared to arise from the different factors and considerations impinging on women and staff at the time of recruitment. While staff placed emphasis on promoting understanding in the emergency situation of RP by imparting information in clear and succinct ways, women highlighted the experiential realities of their pre- and post-birthing situations, and how these had led to quick decisions being made without full engagement with the potential risks of trial participation. To facilitate informed consent, women suggested that trial information should be given during the antenatal period, and, in doing so, articulated a rights-based discourse. Staff, however, voiced opposition to this approach by emphasising a duty of care to all pregnant women, and raising concerns about causing undue distress to the majority of individuals who would not subsequently develop a RP.

Conclusions

By drawing upon the perspectives of women and staff involved in the same trial we have shown that they may operate within different experiential and ethical paradigms. In doing so, we argue for the potential benefits of drawing upon multiple perspectives when developing information and consent pathways used in future (peripartum) trials.

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Literature
1.
McDonald AM, Knight RC, Campbell MK, Entwistle VA, Grant AM, Cook JA, et al. What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies. Trials. 2006;7:9.CrossRefPubMedPubMedCentral
2.
3.
Wragg JA, Robinson EJ, Lilford RJ. Information presentation and decisions to enter clinical trials: a hypothetical trail of hormone replacement therapy. Soc Sci Med. 2000;51(3):453–62.CrossRefPubMed
4.
Donovan J, Mills N, Smith M, Brindle L, Jacoby A, Peters T, et al. Improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. BMJ. 2002;325(7367):766–9.CrossRefPubMedPubMedCentral
5.
Mills N, Blazeby JM, Hamdy FC, Neal DE, Campbell B, Wilson C, et al. Training recruiters to randomized trials to facilitate recruitment and informed consent by exploring patients' treatment preferences. Trials. 2014;15:323.CrossRefPubMedPubMedCentral
6.
Donovan JL, et al. An intervention to improve informed consent and recruitment to randomised clinical trials: the development of the Quintet Recruitment Intervention (QRI). In press – Trials.
7.
Gammelgaard A, Rossel P, Mortensen OS. DANAMI-2 Investigators. Patients’ perceptions of informed consent in acute myocardial infarction research: a Danish study. Soc Sci Med. 2004;58(11):2313–24.CrossRefPubMed
8.
Mangset M, Førde R, Nessa J, Berge E, Wyller TB. I don’t like that, it’s tricking people too much…: acute informed consent to participation in a trial of thrombolysis for stroke. J Med Ethics. 2008;34(10):751–6. doi:10.​1136/​jme.​2007.​023168.CrossRefPubMed
9.
10.
11.
Woolfall K, Frith L, Gamble C, Gilbert R, Mok Q, Young B, et al. How parents and practitioners experience research without prior consent (deferred consent) for emergency research involving children with life threatening conditions: a mixed method study. BMJ Open. 2015;5(9):e008522. doi:10.​1136/​bmjopen-2015-008522.CrossRefPubMedPubMedCentral
12.
13.
Ross S, Grant A, Counsell C, Gillespie W, Russell I, Prescott R. Barriers to participation in randomised controlled trials: a systematic review. J Clin Epidemiol. 1999;52(12):1143–56.CrossRefPubMed
14.
15.
16.
Donovan JL, Salis OC, Toerien MG, Paramasivan S, Hamdy FC, Blazeby JM. The intellectual challenges and emotional consequences of equipoise contributed to the fragility of recruitment in six randomized controlled trials. J Clin Epidemiol. 2014;67:912–20.CrossRefPubMedPubMedCentral
17.
Taylor KM. Integrating conflicting professional roles: physician participation in randomized clinical trials. Soc Sci Med. 1992;35:217–24.CrossRefPubMed
18.
Tam NT, Huy NT, le Thoa TB, Long NP, Trang NT, Hirayama K, et al. Participants’ understanding of informed consent in clinical trials over three decades: systematic review and meta-analysis. Bull World Health Organ. 2015;93(3):186–98H. doi:10.​2471/​BLT.​14.​141390. Epub 22 January 2015.CrossRefPubMedPubMedCentral
19.
Featherstone K, Donovan J. Random allocation or allocation at random: patients’ perspectives of participation in a randomized controlled trial. BMJ. 1998;317:1177–80.CrossRefPubMedPubMedCentral
20.
Fisher JA. Medical research for hire: the political economy of pharmaceutical clinical trials. London: Rutgers University Press; 2009.
21.
Nickel PJ. Vulnerable populations in research: the case of the seriously ill. Theor Med Bioeth. 2006;27(3):245–64.CrossRefPubMed
22.
23.
Abadie R. The professional guinea pig: big pharma and the risky world of human subjects. Durham: Duke University Press; 2010.
24.
Kenyon S, Dixon-Woods M, Jackson CJ, Windridge K, Pitchforth E. Participating in a trial in a critical situation: a qualitative study in pregnancy. Qual Saf Health Care. 2006;15(2):98–101.CrossRefPubMedPubMedCentral
25.
26.
Mason SA, Allmark PJ. Obtaining informed consent to neonatal randomised controlled trials: interviews with parents and clinicians in the Euricon study. Lancet. 2000;356(9247):2045–51.CrossRefPubMed
27.
Helmreich RJ, Hundley V, Norman A, Ighedosa J, Chow E. Research in pregnant women: the challenges of informed consent. Nurs Womens Health. 2007;11(6):576–85.CrossRefPubMed
28.
Shakur H, Elbourne D, Gülmezoglu M, Alfirevic Z, Ronsmans C, Allen E, et al. The WOMAN Trial (World Maternal Antifibrinolytic Trial): tranexamic acid for the treatment of postpartum haemorrhage: an international randomised, double blind placebo controlled trial. Trials. 2010;11:40. doi:10.​1186/​1745-6215-11-40.CrossRefPubMedPubMedCentral
29.
Snowdon C, Brocklehurst P, Tasker R, Ward Platt M, Harvey S, Elbourne D. Death, bereavement and randomised controlled trials (BRACELET): a methodological study of policy and practice in neonatal and paediatric intensive care trials. Health Technol Assess. 2014; 18. doi:10.​3310/​hta18420
30.
NICE. NICE clinical guideline 55: intrapartum care: care of healthy women and their babies during childbirth. 2012.
31.
32.
Pope C, Mays N. Reaching the parts other methods cannot reach: an introduction to qualitative methods in health and health services research. BMJ. 1995;311(6996):42–5. PMCID: PMC2550091.CrossRefPubMedPubMedCentral
33.
Glaser BG, Strauss AL. The discovery of grounded theory. New York: Aldine; 1967.
34.
Strauss A, Corbin J. Basics of qualitative research: grounded theory procedures and techniques. London: Sage; 1990.
35.
Snowdon C, Elbourne D, Garcia J. ‘It was a snap decision’: parental and professional perspectives on the speed of decisions about participation in perinatal randomised controlled trials. Soc Sci Med. 2006;62(9):2279–90. Epub 15 November 2005.CrossRefPubMed
36.
Ayers S, Sawyer A, Düring C, Rabe H. Parents report positive experiences about enrolling babies in a cord-related clinical trial before birth. Acta Paediatr. 2015;104(4):e164–70. doi:10.​1111/​apa.​12922.CrossRefPubMed
37.
38.
RCOG. Clinical governance advice No. 6a. London: RCOG; 2010.
39.
Ferguson PR. Information giving in clinical trials: the views of medical researchers. Bioethics. 2003;17(1):101–11.CrossRefPubMed
40.
Hall XMH, Halliwell R, Carr-Hill R. Concomitant and repeated happenings of complications of the third stage of labour. Br J Obstet Gynaecol. 1985;92:732–8.CrossRefPubMed
41.
Elmir R, Schmied V, Jackson D, Wilkes L. Between life and death: women's experiences of coming close to death, and surviving a severe postpartum haemorrhage and emergency hysterectomy. Midwifery. 2012;28(2):228–35. doi:10.​1016/​j.​midw.​2010.​11.​008. Epub 19 January 2011.CrossRefPubMed
42.
Metadata
Title
Recruiting and consenting into a peripartum trial in an emergency setting: a qualitative study of the experiences and views of women and healthcare professionals
Authors
Julia Lawton
Claire Snowdon
Susan Morrow
Jane E. Norman
Fiona C. Denison
Nina Hallowell
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1323-3

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