Subscribe to RSS
Patient- and Health-Care-Provider-Reported Outcomes to Consider in Research on Pregnancy-Associated Venous ThromboembolismFunding A.K.'s work was funded in part by the Frederick Banting and Charles Best Canadian Graduate Scholarship–Master's Award (CGS M) for May 2019–May 2020 awarded through the Canadian Institutes of Health Research (CIHR).
Background Venous thromboembolism (VTE) in pregnancy can have numerous adverse impacts on patients and health care systems. Ongoing research aimed at improving maternal and fetal/neonatal outcomes is hampered by the lack of patient perspective in determining which outcomes are considered important to assess the effectiveness of interventions.
Objectives The objective of this study was to elicit outcomes from those who experienced or were at risk for pregnancy-associated VTE (health service users, HSUs) and health care providers (HCPs) involved in their care.
Methods Canadian HSUs and HCPs were recruited using convenience and purposive sampling, respectively. Individual, semistructured interviews aimed specifically at eliciting pregnancy-related outcomes were conducted until data saturation was attained. Interviews were audio-recorded and transcribed verbatim. Written transcripts were de-identified and interpretatively analyzed in duplicate to obtain outcomes related to participant experiences. Outcomes were grouped based on a taxonomy developed for medical research and compared between and across interviews with patients and HCPs, and with those obtained through a systematic review of the published literature.
Results and Conclusion We interviewed 10 HSUs and eight HCPs and elicited 52 outcomes, 21 of which have not been reported in the literature. Although the majority of elicited outcomes were in the clinical/physiological core outcome area, both HSUs and HCPs highlighted the importance of outcomes related to functioning/life impact and general wellbeing of mother and baby. These outcomes representing the perspectives of HSUs and HCPs should be considered while conducting trials on pregnancy-associated VTE.
Received: 29 April 2020
Accepted: 15 December 2020
10 February 2021 (online)
© 2021. Thieme. All rights reserved.
Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany
- 1 James AH. Venous thromboembolism in pregnancy. Arterioscler Thromb Vasc Biol 2009; 29 (03) 326-331
- 2 Knight M, Nair M, Tuffnell D, Shakespeare J, Kenyon S, Kurinczuk J. on behalf of MBRRACE-UK. Saving Lives, Improving Mothers' Care: lessons learned to inform maternity care from the UK and Ireland Confidential Enquiries into Maternal Deaths and Morbidity 2015–17. Oxford: National Perinatal Epidemiology Unit, University of Oxford; 2019
- 3 Rokyta R, Hutyra M, Jansa P. 2014 ESC guidelines on the diagnosis and management of acute pulmonary embolism. Summary document prepared by the Czech Society of Cardiology. Cor Vasa 2015; 57: e275-e296
- 4 Wik HS, Jacobsen AF, Sandvik L, Sandset PM. Prevalence and predictors for post-thrombotic syndrome 3 to 16 years after pregnancy-related venous thrombosis: a population-based, cross-sectional, case-control study. J Thromb Haemost 2012; 10 (05) 840-847
- 5 Wik HS, Jacobsen AF, Sandvik L, Sandset PM. Long-term impact of pregnancy-related venous thrombosis on quality-of-life, general health and functioning: results of a cross-sectional, case-control study. BMJ Open 2012; 2 (06) e002048
- 6 Chess LE, Gagnier JJ. Applicable or non-applicable: investigations of clinical heterogeneity in systematic reviews. BMC Med Res Methodol 2016; 16: 19
- 7 D'Souza R, Shah PS, Sander B. Clinical decision analysis in perinatology. Acta Obstet Gynecol Scand 2018; 97 (04) 491-499
- 8 Dadouch R, Faheim M, Susini O, Sedra S, Showell M, D'Souza R. COSSOPP investigators. Variation in outcome reporting in studies on obesity in pregnancy – a systematic review. Clin Obes 2019; 9 (06) e12341
- 9 Dodd S, Clarke M, Becker L, Mavergames C, Fish R, Williamson PR. A taxonomy has been developed for outcomes in medical research to help improve knowledge discovery. J Clin Epidemiol 2018; 96: 84-92
- 10 Dickinson F, McCauley M, Smith H, van den Broek N. Patient reported outcome measures for use in pregnancy and childbirth: a systematic review. BMC Pregnancy Childbirth 2019; 19 (01) 155
- 11 Outcome Reporting in Obstetric Studies (OROS) Project. Department of Obstetrics & Gynecology, University of Toronto; 2020. . Accessed December 14, 2020 at: https://www.obgyn.utoronto.ca/oros-project
- 12 King A, D'Souza R, Teshler L, Shehata N, Malinowski AK. Development of a core outcome set for studies on prevention and management of pregnancy-associated venous thromboembolism (COSPVenTE): a study protocol. BMJ Open 2020; 10 (07) e034017
- 13 Williamson PR, Altman DG, Bagley H. et al. The COMET Handbook: version 1.0. Trials 2017; 18 (Suppl. 03) 280
- 14 Core Outcome Measures in Effectiveness Trials. 2011 . December 14, 2020 at: http://www.comet-initiative.org
- 15 Khan K. The CROWN Initiative: journal editors invite researchers to develop core outcomes in women's health. BJOG 2014; 121 (10) 1181-1182
- 16 Core Outcomes in Women's and Newborn health. 2017 . Accessed December 14, 2020 at: http://www.crown-initiative.org
- 17 Hughes KL, Clarke M, Williamson PR. A systematic review finds core outcome set uptake varies widely across different areas of health. J Clin Epidemiol 2020; 129: 114-123
- 18 King A, D'Souza R, Herman D, Shehata N, Malinowski AK. Outcome reporting in studies on perinatal venous thromboembolism: a systematic review [28O]. Obstet Gynaecol 2020; 135: 164S
- 19 Elfil M, Negida A. Sampling methods in clinical research; an educational review. Emerg (Tehran) 2017; 5 (01) e52
- 20 Palinkas LA, Horwitz SM, Green CA, Wisdom JP, Duan N, Hoagwood K. Purposeful sampling for qualitative data collection and analysis in mixed method implementation research. Adm Policy Ment Health 2015; 42 (05) 533-544
- 21 Green J, Thorogood N. Qualitative Methods for Health Research. 3rd ed.. London: SAGE Publications; 2014
- 22 Duffy J, Thompson T, Hinton L, Salinas M, McManus RJ, Ziebland S. International Collaboration to Harmonise Outcomes in Pre-eclampsia (iHOPE) Qualitative Research Group. What outcomes should researchers select, collect and report in pre-eclampsia research? A qualitative study exploring the views of women with lived experience of pre-eclampsia. BJOG 2019; 126 (05) 637-646
- 23 Hall C, D'Souza RD. Patients and health care providers identify important outcomes for research on pregnancy and heart disease. CJC Open 2020; 2 (06) 454-461
- 24 Keeley T, Williamson P, Callery P. et al. The use of qualitative methods to inform Delphi surveys in core outcome set development. Trials 2016; 17 (01) 230
- 25 Kaufman J, Ryan R, Hill S. Qualitative focus groups with stakeholders identify new potential outcomes related to vaccination communication. PLoS One 2018; 13 (08) e0201145
- 26 Pope C, Mays N, Popay J. Synthesising Qualitative and Quantitative Health Evidence: A Guide to Methods. London: McGraw-Hill Education (UK); 2007
- 27 Barry CA, Britten N, Barber N, Bradley C, Stevenson F. Using reflexivity to optimize teamwork in qualitative research. Qual Health Res 1999; 9 (01) 26-44
- 28 Lincoln Y, Gupta E. Naturalistic Inquiry. Newbury Park, CA: Sage Publications; 1985
- 29 Al-Busaidi ZQ. Qualitative research and its uses in health care. Sultan Qaboos Univ Med J 2008; 8 (01) 11-19
- 30 Downe S, Finlayson K, Oladapo OT, Bonet M, Gülmezoglu AM. What matters to women during childbirth: a systematic qualitative review. PLoS One 2018; 13 (04) e0194906
- 31 Mogos MF, August EM, Salinas-Miranda AA, Sultan DH, Salihu HM. A Systematic review of quality of life measures in pregnant and postpartum mothers. Appl Res Qual Life 2013; 8 (02) 219-250