The DOI matches its Crossref record; 4 of the 4 references it cites were found in a registry or an index.
Development of a Core Outcome Set for Studies on Cardiac Disease in Pregnancy (COSCarP): a study protocol
Open accessAbstract
Background: Clinical studies looking at interventions to optimize pregnancy and long-term outcomes for women with cardiac disease and their babies are inconsistent in their reporting of clinical outcomes, making it difficult to compare results across studies and draw meaningful conclusions. The development of a core outcome set (COS)—a standardized, minimum set of outcomes that must be collected and reported in all studies—is a practical solution to this problem. Methods/design: We will follow a five-step process in developing a COS for studies on pregnant women with cardiac disease. First, a systematic literature review will identify all reported outcomes (including patient-reported outcomes) and definitions. Second, semi-structured interviews with stakeholders involved in the care of pregnant women with cardiac disease will determine their perspective and add new outcomes that they consider important. Third, an international electronic Delphi survey will narrow outcomes obtained through the first two steps, in an attempt to arrive at a consensus. Fourth, a face-to-face consensus meeting will deliberate to finalize the COS. Finally, measurement tools and definitions for included outcomes will be determined through a series of literature reviews and Delphi surveys. Discussion: This protocol provides an overview of the steps involved in the development of a COS that must be reported in studies involving pregnant women with cardiac disease, in an attempt to harmonize outcome reporting and ensure the validity of study results that will not only inform clinical practice and future research but also encourage the development of COS in other areas of medicine. COMET core outcome set registration: http://www.cometinitiative.org/studies/details/834
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Although the FDA regulation seems to provide clearly defined guidance for the conduct of emergency research, several authors have previously attributed to it significant procedural impediments.
“Although this regulation seems to provide clearly defined guidance for the conduct of emergency research, several authors have previously attributed to it significant procedural impediments. 346,347”
From European Resuscitation Council Guidelines 2021: Ethics of resuscitation and end of life decisions (2021) · cites this paper as [346]
The Methods/design passages address consent for Delphi survey participants and challenges in developing a core outcome set for cardiac disease in pregnancy. Searches for FDA emergency-research regulation and procedural impediments found no passage addressing the cited claim. (LLM, conf=0.75)
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Developing core outcome sets for clinical trials: issues to consider
Williamson, P. R., Altman, D. G., Blazeby, J. M., Clarke, M., Devane, D., Gargon, E., & Tugwell, P. (2012) · Trials · doi:10.1186/1745-6215-13-132 · Cited by 1,661
Sinha, I. P., Smyth, R. L., & Williamson, P. R. (2011) · PLoS Medicine · doi:10.1371/journal.pmed.1000393 · Cited by 891
A taxonomy has been developed for outcomes in medical research to help improve knowledge discovery
Dodd, S., Clarke, M., Becker, L., Mavergames, C., Fish, R., & Williamson, P. R. (2018) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2017.12.020 · Cited by 625
Knight, M. (2017) · National Perinatal Epidemiology Unit, University of Oxford · doi:10.5287/ora-nrymp8wxq · Cited by 541
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Research works printed but not linked: 20
- Elkayam U, Goland S, Pieper PG, Silverside CK. High-risk cardiac disease in pregnancy: part I. J Am Coll Cardiol. 2016;68(4):396–410. · DOI
- Elkayam U, Goland S, Pieper PG, Silverside CK. High-risk cardiac disease in pregnancy: part II. J Am Coll Cardiol. 2016;68(4):502–16. · DOI
- Creanga AA, Berg CJ, Syverson C, Seed K, Bruce FC, Callaghan WM. Pregnancy-related mortality in the United States, 2006-2010. Obstet Gynecol. 2015;125(1):5–12. · DOI
- Mocumbi AO, Sliwa K, Soma-Pillay P. Medical disease as a cause of maternal mortality: the pre-imminence of cardiovascular pathology. Cardiovasc J Afr. 2016;27(2):84–8. · DOI
- Canobbio MM, Warnes CA, Aboulhosn J, et al. Management of pregnancy in patients with complex congenital heart disease: a scientific statement for healthcare professionals from the American Heart Association. Circulation. 2017;135(8):e50–87. · DOI
- Williamson PR, Altman DG, Bagley H, et al. The COMET handbook: version 1.0. Trials. 2017;18(Suppl 3):280. · DOI · Paper page
- Kirkham JJ, Gorst S, Altman DG, et al. Core outcome set--STAndardised Protocol Items: the COS-STAP statement. Trials. 2019;20(1):116. · DOI
- D’Souza R, OROS-investigators. Outcome Reporting in Obstetric Studies (OROS) project. 2019; https://www.obgyn.utoronto.ca/oros-project. Accessed 14 Feb 2020.
- D'Souza R, Silversides CK, Sermer M, et al. Developing a core outcome set for pregnant women with cardiac disease. 2016; http://www.comet-initiative.org/studies/details/834. Accessed 10 Dec 2019.
- Harman NL, Bruce IA, Callery P, et al. MOMENT--Management of Otitis Media with Effusion in Cleft Palate: protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey. Trials. 2013;14:70. · DOI
- D'Souza R, Shah PS, Sander B. Clinical decision analysis in perinatology. Acta Obstet Gynecol Scand. 2017;97:491–9. · DOI
- D'Souza R, Ostro J, Shah PS, et al. Anticoagulation for pregnant women with mechanical heart valves: a systematic review and meta-analysis. Eur Heart J. 2017;38(19):1509–16. · DOI
- D'Souza R, Soete E, Silversides CK, et al. Pregnancy outcomes following cardiac transplantation. J Obstetrics Gynaecol. 2018;40(5):566–71.
- Duffy JMN, Hirsch M, Ziebland S, McManus RJ, International Collaboration to Harmonise Outcomes in P-e. Methodological decisions influence the identification of potential core outcomes in pre-eclampsia related studies: a sensitivity analysis informing the development of guidelines for future core outcome set developers. BJOG. 2019;126(12):1482–90. https://doi.org/10.1111/1471-0528.15892. · DOI
- Dadouch R, Hall C, Du Mont J, D'Souza R. Obesity in Pregnancy - Patient-Reported Outcomes in Qualitative Research: A Systematic Review. J Obstet Gynaecol Can. 2020; https://doi.org/10.1016/j.jogc.2019.09.011. · DOI
- Dadouch R, Faheim M, Juando-Prats C, Parsons J, D'Souza R, Investigators C. Development of a Core Outcome Set for Studies on Obesity in Pregnant Patients (COSSOPP): a study protocol. Trials. 2018;19(1):655. · DOI
- Guyatt GH, Oxman AD, Kunz R, et al. GRADE guidelines: 2. Framing the question and deciding on important outcomes. J Clin Epidemiol. 2011;64(4):395–400. · DOI · Paper page
- Duffy J, Rolph R, Gale C, et al. Core outcome sets in women's and newborn health: a systematic review. BJOG. 2017;124(10):1481–9. · DOI
- Mokkink LB, Terwee CB, Patrick DL, et al. The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments: an international Delphi study. Qual Life Res. 2010;19(4):539–49. · DOI · Paper page
- Prinsen CA, Vohra S, Rose MR, et al. How to select outcome measurement instruments for outcomes included in a “Core Outcome Set” - a practical guideline. Trials. 2016;17(1):449. · DOI · Paper page
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European Resuscitation Council Guidelines 2021: Ethics of resuscitation and end of life decisions
Mentzelopoulos, S. D., Couper, K., Voorde, P. V. D., Druwé, P., Blom, M., Perkins, G. D., Lulic, I., Djakow, J., Raffay, V., Lilja, G., et al. (2021) · Resuscitation · doi:10.1016/j.resuscitation.2021.02.017 · Cited by 246
Metadata
- Authors
- D’Souza, R., Hall, C., Sermer, M., Siu, S., & Silversides, C.
- Affiliations
- Mount Sinai Hospital (CA)
- Western University (CA)
- ORCID
- Siu, Samuel
- Venue
- Trials
- Published
- 2020-03-30
- Volume
- 21
- Issue
- 1
- Pages
- 300-300
- ISSN
- 1745-6215 (ISSN-L)
- PMC
- PMC7106670
- OpenAlex
- W3013427275
- Cited by
- 24
- References
- 4
- Citations by year
- 2026: 1 · 2025: 4 · 2024: 1 · 2023: 2 · 2022: 1 · 2021: 11 · 2020: 3
- FWCI
- 5.69
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- Trials (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- TSpace (University of Toronto) (submittedVersion, other-oa)
- Scholarship@Western (Western University) (submittedVersion, other-oa)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Scholarship@Western (Western University) (submittedVersion)
- Funders
- Tolnai Grant (410010150)
- Topics
- Social Sciences › Sociology and Political Science › Delphi Technique in Research
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiovascular Issues in Pregnancy
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Clinical practice guidelines implementation
- Keywords
- core outcome set, cardiac disease in pregnancy, pregnancy outcomes, patient-reported outcomes, stakeholder perspectives, Delphi consensus, outcome definitions
- MeSH terms
- Patient Reported Outcome Measures, Systematic Reviews as Topic, Delphi Technique, Female, Heart Diseases, Humans, Interviews as Topic, Pregnancy, Pregnancy Complications, Cardiovascular, Surveys and Questionnaires, Research Design, Meta-Analysis as Topic, Endpoint Determination, Consensus, Qualitative Research
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