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Decision Analysis in SHared decision making for Thromboprophylaxis during Pregnancy (DASH-TOP): a sequential explanatory mixed-methods pilot study
  1. Brittany Humphries1,
  2. Montserrat León-García2,3,
  3. Shannon M Bates4,
  4. Gordon Guyatt1,4,
  5. M H Eckman5,
  6. Rohan D'Souza1,6,
  7. Nadine Shehata7,
  8. Susan M Jack1,8,
  9. Pablo Alonso-Coello2,
  10. Feng Xie1,9
  1. 1Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada
  2. 2Iberoamerican Cochrane Center, Biomedical Research Institute Sant Pau (IIB Sant Pau), Barcelona, Spain
  3. 3Department of Pediatrics, Obstetrics, Gynaecology and Preventive Medicine, Universidad Autónoma de Barcelona, Barcelona, Spain
  4. 4Department of Medicine, McMaster University, Hamilton, Ontario, Canada
  5. 5Division of General Internal Medicine and Center for Clinical Effectiveness, University of Cincinnati, Cincinnati, Ohio, USA
  6. 6Department of Obstetrics & Gynecology, McMaster University, Hamilton, Ontario, Canada
  7. 7Departments of Medicine, Laboratory Medicine and Pathobiology, Mount Sinai Hospital, Toronto, Ontario, Canada
  8. 8School of Nursing, McMaster University, Hamilton, Ontario, Canada
  9. 9Centre for Health Economics and Policy Analysis, McMaster University, Hamilton, Ontario, Canada
  1. Correspondence to Dr Feng Xie, Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Canada; fengxie{at}mcmaster.ca; Dr Pablo Alonso-Coello, Iberoamerican Cochran Center, Biomedical Research Institute Sant Pau (IIB Sant Pau), Barcelona, Spain; palonso{at}santpau.cat

Abstract

Objectives To gain insight into formal methods of integrating patient preferences and clinical evidence to inform treatment decisions, we explored patients’ experience with a personalised decision analysis intervention, for prophylactic low-molecular-weight heparin (LMWH) in the antenatal period.

Design Mixed-methods explanatory sequential pilot study.

Setting Hospitals in Canada (n=1) and Spain (n=4 sites). Due to the COVID-19 pandemic, we conducted part of the study virtually.

Participants 15 individuals with a prior venous thromboembolism who were pregnant or planning pregnancy and had been referred for counselling regarding LMWH.

Intervention A shared decision-making intervention that included three components: (1) direct choice exercise; (2) preference elicitation exercises and (3) personalised decision analysis.

Main outcome measures Participants completed a self-administered questionnaire to evaluate decision quality (decisional conflict, self-efficacy and satisfaction). Semistructured interviews were then conducted to explore their experience and perceptions of the decision-making process.

Results Participants in the study appreciated the opportunity to use an evidence-based decision support tool that considered their personal values and preferences and reported feeling more prepared for their consultation. However, there were mixed reactions to the standard gamble and personalised treatment recommendation. Some participants could not understand how to complete the standard gamble exercises, and others highlighted the need for more informative ways of presenting results of the decision analysis.

Conclusion Our results highlight the challenges and opportunities for those who wish to incorporate decision analysis to support shared decision-making for clinical decisions.

  • haematology
  • maternal medicine
  • thromboembolism
  • clinical decision-making
  • methods

Data availability statement

Data are available on reasonable request.

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Data availability statement

Data are available on reasonable request.

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Footnotes

  • Twitter @FengtasticXie

  • Contributors The DASH-TOP study is led by co-PIs, FX and PA-C who are the guarantors of the study, with the support of SMB, GG, MHE, SMJ, RD’S, NS, ML-G and BH. FX, PA-C, SMB and GG conceptualised the study. The decision analysis intervention was developed by MHE. ML-G and BH developed other components of the intervention with support of the DASH-TOP team. BH was responsible for conducting data collection at the Canadian study site, while ML-G was responsible for data collection at the Spanish sites. All members of the DASH-TOP team contributed to study planning, data analysis and write up.

  • Funding BH received a doctoral award from the Canadian Institutes for Health Research (Grant number: GSD—152327). Montserrat León-García receives doctoral support from the Spanish Public Research Institute—Health Institute Carlos III (Grant number F18/00014). The study is partially funded by the Spanish Public Research Institute – Health Institute Carlos III (Grant number: PI17/01874).

  • Competing interests MHE has received grant funding from the NIH (NICHD and NCATS), and funding for investigator-initiated research from Bristol-Myers Squibb. RD’S has received speaking honoraria and grant funding from Ferring, and an early career grant from the Canadian Institutes for Health Research for projects unrelated to this study. NS has received honoraria and an educational grant from Sanofi. SMB has acted as a consultant for Leo Pharma Canada (manufacturer of low-molecular-weight heparin) and receives unencumbered salary support through the McMaster University Eli Lilly Canada-May Cohen Chair in Women’s Health. ML-G declares no conflict of interest. BH is currently employed by Cytel.

  • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

  • Provenance and peer review Not commissioned; externally peer reviewed.