IDEAS home Printed from https://ideas.repec.org/a/eee/socmed/v68y2009i11p2018-2028.html
   My bibliography  Save this article

It's not just what you say, it's also how you say it: Opening the 'black box' of informed consent appointments in randomised controlled trials

Author

Listed:
  • Wade, Julia
  • Donovan, Jenny L.
  • Athene Lane, J.
  • Neal, David E.
  • Hamdy, Freddie C.

Abstract

Randomised controlled trials (RCTs) represent the gold standard methodology for determining effectiveness of healthcare interventions. Poor recruitment to RCTs can threaten external validity and waste resources. An inherent tension exists between safeguarding informed decision-making by participants and maximising numbers enrolled. This study investigated what occurs during informed consent appointments in an ongoing multi-centre RCT in the UK. Objectives were to investigate: 1] how study staff presented study information to participants; 2] what evidence emerged as to how well-informed participants were when proceeding to randomisation or treatment selection; and 3] what aspects of the communication process may facilitate improvements in providing evidence of informed consent. Qualitative analysis of a purposive sample of 23 recruitment appointments from three study centres and involving several recruitment staff applied techniques of thematic, content and conversation analysis (CA). Thematic analysis and CA revealed variation in appointment content and structure. Appointments were mostly recruiter-led or participant-led, and this structure was associated with what evidence emerged as to how participants understood information provided and whether they were in equipoise. Participant-led appointments provided this evidence more consistently. Detailed CA identified communication techniques which, when employed by recruiters, provided evidence as to how participants understood the choices before them. Strategic use of open questions, pauses and ceding the floor in the interaction facilitated detailed and systematic exploration of each participant's concerns and position regarding equipoise. We conclude that the current focus on content to be provided to achieve informed consent should be broadened to encompass consideration of how information is best conveyed to potential participants. A model of tailored information provision using the communication techniques identified and centred on eliciting and addressing participants' concerns is proposed. Use of these techniques is necessary to make potential participants' understanding of key issues and their position regarding equipoise explicit in order to facilitate truly informed consent.

Suggested Citation

  • Wade, Julia & Donovan, Jenny L. & Athene Lane, J. & Neal, David E. & Hamdy, Freddie C., 2009. "It's not just what you say, it's also how you say it: Opening the 'black box' of informed consent appointments in randomised controlled trials," Social Science & Medicine, Elsevier, vol. 68(11), pages 2018-2028, June.
    • Handle: RePEc:eee:socmed:v:68:y:2009:i:11:p:2018-2028
    as

    Download full text from publisher

    File URL: http://www.sciencedirect.com/science/article/pii/S0277-9536(09)00105-1
    Download Restriction: Full text for ScienceDirect subscribers only
    ---><---

    As the access to this document is restricted, you may want to search for a different version of it.

    References listed on IDEAS

    as
    1. Arora, Neeraj K., 2003. "Interacting with cancer patients: the significance of physicians' communication behavior," Social Science & Medicine, Elsevier, vol. 57(5), pages 791-806, September.
    2. Brown, R. F. & Butow, P. N. & Butt, D. G. & Moore, A. R. & Tattersall, M. H. N., 2004. "Developing ethical strategies to assist oncologists in seeking informed consent to cancer clinical trials," Social Science & Medicine, Elsevier, vol. 58(2), pages 379-390, January.
    3. Robinson, Elizabeth J. & Kerr, Cicely & Stevens, Andrew & Lilford, Richard & Braunholtz, David & Edwards, Sarah, 2004. "Lay conceptions of the ethical and scientific justifications for random allocation in clinical trials," Social Science & Medicine, Elsevier, vol. 58(4), pages 811-824, February.
    4. Dixon-Woods, Mary & Ashcroft, Richard E. & Jackson, Clare J. & Tobin, Martin D. & Kivits, Joelle & Burton, Paul R. & Samani, Nilesh J., 2007. "Beyond "misunderstanding": Written information and decisions about taking part in a genetic epidemiology study," Social Science & Medicine, Elsevier, vol. 65(11), pages 2212-2222, December.
    5. Bower, Peter & King, Michael & Nazareth, Irwin & Lampe, Fiona & Sibbald, Bonnie, 2005. "Patient preferences in randomised controlled trials: Conceptual framework and implications for research," Social Science & Medicine, Elsevier, vol. 61(3), pages 685-695, August.
    6. Brown, R.F & Butow, P.N & Ellis, P & Boyle, F & Tattersall, M.H.N, 2004. "Seeking informed consent to cancer clinical trials:: describing current practice," Social Science & Medicine, Elsevier, vol. 58(12), pages 2445-2457, June.
    7. Gattellari, Melina & Butow, Phyllis N. & Tattersall, Martin H. N., 2001. "Sharing decisions in cancer care," Social Science & Medicine, Elsevier, vol. 52(12), pages 1865-1878, June.
    8. Ong, L. M. L. & de Haes, J. C. J. M. & Hoos, A. M. & Lammes, F. B., 1995. "Doctor-patient communication: A review of the literature," Social Science & Medicine, Elsevier, vol. 40(7), pages 903-918, April.
    9. Edwards, Sarah J. L. & Lilford, Richard J. & Thornton, Jim & Hewison, Jenny, 1998. "Informed consent for clinical trials: in search of the "best" method," Social Science & Medicine, Elsevier, vol. 47(11), pages 1825-1840, December.
    10. Schwabe, Meike & Howell, Stephen J. & Reuber, Markus, 2007. "Differential diagnosis of seizure disorders: A conversation analytic approach," Social Science & Medicine, Elsevier, vol. 65(4), pages 712-724, August.
    11. Charles, Cathy & Gafni, Amiram & Whelan, Tim, 1999. "Decision-making in the physician-patient encounter: revisiting the shared treatment decision-making model," Social Science & Medicine, Elsevier, vol. 49(5), pages 651-661, September.
    12. Boulton, Mary & Parker, Michael, 2007. "Informed consent in a changing environment," Social Science & Medicine, Elsevier, vol. 65(11), pages 2187-2198, December.
    13. Chard, J. A. & Lilford, R. J., 1998. "The use of equipoise in clinical trials," Social Science & Medicine, Elsevier, vol. 47(7), pages 891-898, October.
    14. Featherstone, Katie & Donovan, Jenny L., 2002. ""Why don't they just tell me straight, why allocate it?" The struggle to make sense of participating in a randomised controlled trial," Social Science & Medicine, Elsevier, vol. 55(5), pages 709-719, September.
    Full references (including those not matched with items on IDEAS)

    Citations

    Citations are extracted by the CitEc Project, subscribe to its RSS feed for this item.
    as


    Cited by:

    1. Stewart, Simon John & Roberts, Lisa & Brindle, Lucy, 2023. "Shared decision-making during prostate cancer consultations: Implications of clinician misalignment with patient and partner preferences," Social Science & Medicine, Elsevier, vol. 329(C).

    Most related items

    These are the items that most often cite the same works as this one and are cited by the same works as this one.
    1. Bower, Peter & King, Michael & Nazareth, Irwin & Lampe, Fiona & Sibbald, Bonnie, 2005. "Patient preferences in randomised controlled trials: Conceptual framework and implications for research," Social Science & Medicine, Elsevier, vol. 61(3), pages 685-695, August.
    2. Timmermans, Stefan & Tietbohl, Caroline, 2018. "Fifty years of sociological leadership at Social Science and Medicine," Social Science & Medicine, Elsevier, vol. 196(C), pages 209-215.
    3. Fraser, Suzanne & Fomiatti, Renae & Moore, David & Seear, Kate & Aitken, Campbell, 2020. "Is another relationship possible? Connoisseurship and the doctor–patient relationship for men who consume performance and image-enhancing drugs," Social Science & Medicine, Elsevier, vol. 246(C).
    4. Sarradon-Eck, Aline & Sakoyan, Juliette & Desclaux, Alice & Mancini, Julien & Genre, Dominique & Julian-Reynier, Claire, 2012. ""They should take time": Disclosure of clinical trial results as part of a social relationship," Social Science & Medicine, Elsevier, vol. 75(5), pages 873-882.
    5. Putniņa, Aivita, 2013. "Bioethics and power: Informed consent procedures in post-socialist Latvia," Social Science & Medicine, Elsevier, vol. 98(C), pages 340-344.
    6. Hardman, Doug & Geraghty, Adam W.A. & Lown, Mark & Bishop, Felicity L., 2020. "Subjunctive medicine: Enacting efficacy in general practice," Social Science & Medicine, Elsevier, vol. 245(C).
    7. Hallowell, Nina & Cooke, Sarah & Crawford, Gill & Lucassen, Anneke & Parker, Michael, 2009. "Distinguishing research from clinical care in cancer genetics: Theoretical justifications and practical strategies," Social Science & Medicine, Elsevier, vol. 68(11), pages 2010-2017, June.
    8. Abhyankar, Purva & Velikova, Galina & Summers, Barbara & Bekker, Hilary L., 2016. "Identifying components in consent information needed to support informed decision making about trial participation: An interview study with women managing cancer," Social Science & Medicine, Elsevier, vol. 161(C), pages 83-91.
    9. Coleman-Brueckheimer, Kate & Spitzer, Joseph & Koffman, Jonathan, 2009. "Involvement of Rabbinic and communal authorities in decision-making by haredi Jews in the UK with breast cancer: An interpretative phenomenological analysis," Social Science & Medicine, Elsevier, vol. 68(2), pages 323-333, January.
    10. Budych, Karolina & Helms, Thomas M. & Schultz, Carsten, 2012. "How do patients with rare diseases experience the medical encounter? Exploring role behavior and its impact on patient–physician interaction," Health Policy, Elsevier, vol. 105(2), pages 154-164.
    11. Moumjid, Nora & Gafni, Amiram & Bremond, Alain & Carrere, Marie-Odile, 2007. "Seeking a second opinion: Do patients need a second opinion when practice guidelines exist?," Health Policy, Elsevier, vol. 80(1), pages 43-50, January.
    12. Katherine Treiman & Lauren McCormack & Murrey Olmsted & Nancy Roach & Bryce B. Reeve & Christa E. Martens & Rebecca R. Moultrie & Hanna Sanoff, 2017. "Engaging Patient Advocates and Other Stakeholders to Design Measures of Patient-Centered Communication in Cancer Care," The Patient: Patient-Centered Outcomes Research, Springer;International Academy of Health Preference Research, vol. 10(1), pages 93-103, February.
    13. Lowton, Karen, 2005. "Trials and tribulations: Understanding motivations for clinical research participation amongst adults with cystic fibrosis," Social Science & Medicine, Elsevier, vol. 61(8), pages 1854-1865, October.
    14. Flynn, Kathryn E. & Smith, Maureen A. & Vanness, David, 2006. "A typology of preferences for participation in healthcare decision making," Social Science & Medicine, Elsevier, vol. 63(5), pages 1158-1169, September.
    15. Miller, Nancy & Weinstein, Marcie, 2007. "Participation and knowledge related to a nursing home admission decision among a working age population," Social Science & Medicine, Elsevier, vol. 64(2), pages 303-313, January.
    16. Beach, Wayne A. & Easter, David W. & Good, Jeffrey S. & Pigeron, Elisa, 2005. "Disclosing and responding to cancer "fears" during oncology interviews," Social Science & Medicine, Elsevier, vol. 60(4), pages 893-910, February.
    17. Karnieli-Miller, Orit & Eisikovits, Zvi, 2009. "Physician as partner or salesman? Shared decision-making in real-time encounters," Social Science & Medicine, Elsevier, vol. 69(1), pages 1-8, July.
    18. Paul C. Schroy III & Karen Emmons & Ellen Peters & Julie T. Glick & Patricia A. Robinson & Maria A. Lydotes & Shamini Mylvanaman & Stephen Evans & Christine Chaisson & Michael Pignone & Marianne Prout, 2011. "The Impact of a Novel Computer-Based Decision Aid on Shared Decision Making for Colorectal Cancer Screening," Medical Decision Making, , vol. 31(1), pages 93-107, January.
    19. Jaime Moore & Matthew Haemer & Nazrat Mirza & Ying Z Weatherall & Joan Han & Caren Mangarelli & Mary Jane Hawkins & Stavra Xanthakos & Robert Siegel, 2019. "Pilot Testing of a Patient Decision Aid for Adolescents with Severe Obesity in US Pediatric Weight Management Programs within the COMPASS Network," IJERPH, MDPI, vol. 16(10), pages 1-12, May.
    20. Kevin Mertz & Romil F. Shah & Sara L. Eppler & Jeffrey Yao & Marc Safran & Ariel Palanca & Serena S. Hu & Michael Gardner & Derek F. Amanatullah & Robin N. Kamal, 2020. "A Simple Goal Elicitation Tool Improves Shared Decision Making in Outpatient Orthopedic Surgery: A Randomized Controlled Trial," Medical Decision Making, , vol. 40(6), pages 766-773, August.

    Corrections

    All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:eee:socmed:v:68:y:2009:i:11:p:2018-2028. See general information about how to correct material in RePEc.

    If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

    If CitEc recognized a bibliographic reference but did not link an item in RePEc to it, you can help with this form .

    If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: Catherine Liu (email available below). General contact details of provider: http://www.elsevier.com/wps/find/journaldescription.cws_home/315/description#description .

    Please note that corrections may take a couple of weeks to filter through the various RePEc services.

    IDEAS is a RePEc service. RePEc uses bibliographic data supplied by the respective publishers.