Project Description: More Canadians are living with obesity, in turn resulting in the rise of obesity in pregnancy. A BMI>30 elevates the risk of adverse maternal and offspring health outcomes, exacerbated by weight stigma. Pre-pregnancy interventions are limited and most pregnancies are unplanned, thus many interventions are conducted during the antepartum and peripartum periods. However poor outcome reporting compromises study usability for future research and translation to clinical care. Ambiguously chosen clinical trial outcomes lack representation of all relevant stakeholders, limiting patient-centred care, and outcomes vary between studies in choice and measurements, limiting study comparability upon data aggregation. To address these issues, we propose a core outcome set: the minimum set of outcomes to be reported in future trials as agreed upon by various stakeholders. We will utilize consensus methodologies on outcomes distilled from the literature and qualitative research, with involvement from patients and professionals (physicians, nurses, social workers, researchers, administrators, etc.)

Principal Investigator: Dr. Rohan D’Souza

Collaborators: Rachel Dadouch, Dr. John Kingdom, Dr. Janet Parsons, Dr. Rory Windrim and Dr. Cynthia Maxwell

Funding: 

1. The Bernard Ludwig Studentship in Obstetrics and Gynaecology at Mount Sinai Hospital
2. The Ontario Graduate Student Scholarship awarded to Rachel Dadouch

Progress: 

• Protocol – Published
• Phase 1 – a. Systematic Review – Published  b. Systematic Review of Qualitative Studies – Published
• Phase 2 – Focus groups/individual interviews – preliminary findings being written up
• Phase 3 – Delphi survey – completed.
• Phase 4 – Consensus meeting – TBA
• Phase 5 – Determination of outcome definition and measurement – TBA

Publications: 

Dadouch R, Faheim M, Juando-Prats C, Parsons J, D’Souza R. Development of a Core Outcome Set for Studies on Obesity in Pregnant Patients (COSSOPP): a study protocol. Trials. 2018 Nov 27;19(1):655. doi: 10.1186/s13063-018-3029-1. PMID: 30482249; PMCID: PMC6258169.

Dadouch R, Faheim M, Susini O, Sedra S, Showell M, D’Souza R. Variation in outcome reporting in studies on obesity in pregnancy-A systematic review. Clin Obes. 2019 Dec;9(6):e12341. doi: 10.1111/cob.12341. Epub 2019 Sep 16. PMID: 31525825.

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 Aug;42(8):1001-1011. doi: 10.1016/j.jogc.2019.09.011. Epub 2020 Jan 25. PMID: 31987757.

Project Description: Increasing number of women with cardiac disease are undergoing pregnancy as a result of diagnostic and treatment advances during childhood and adolescence. The profound cardiovascular changes during pregnancy pose unique challenges to women with pre-existing cardiac disease and result in significant maternal and offspring morbidity and mortality. Trials and cohort studies evaluating therapeutic interventions in women with cardiac disease report many different outcomes resulting in significant outcome reporting bias and an inability to compare results across studies. The development and use of core outcome sets would help to address these issues.

Principal Investigator: Dr. Rohan D’Souza

Collaborators: Chelsea Hall, Dr. Candice Silversides, Dr. Mathew Sermer, Dr. Samuel Siu, Dr. Robin Thurman, Dr. Paula Williamson and Dr. Ankita Pal

Funding: Tolnai Grant 2018

Progress: 

• Protocol – Published
• Phase 1 – Systematic review – submitted
• Phase 2 – Qualitative interviews – Published
• Phase 3 – Delphi process – completed
• Phase 4 – Consensus meeting – TBA
• Phase 5 – Determination of outcome definition and measurement – TBA

Publications: 

D’Souza R, Hall C, Sermer M, Siu S, Silversides C. Development of a Core Outcome Set for Studies on Cardiac Disease in Pregnancy (COSCarP): a study protocol. Trials. 2020 Mar 30;21(1):300. doi: 10.1186/s13063-020-04233-1. PMID: 32228655; PMCID: PMC7106670.

Hall C, D’Souza RD. Patients and Health Care Providers Identify Important Outcomes for Research on Pregnancy and Heart Disease. CJC Open. 2020 Jun 4;2(6):454-461. doi: 10.1016/j.cjco.2020.05.010. PMID: 33305204; PMCID: PMC7710929.

Project Description: Vasa Previa, a condition in which fetal vessels are present outside of the umbilical cord and course through fetal membranes, is reported to affect between 1:1275 to 1:5000 spontaneous pregnancies, and 1:202 pregnancies that result from in vitro fertilization. The proximity of the vessels to the internal os of the cervix increases the risk of haemorrhage upon spontaneous or artificial rupture of the membranes resulting in serious complications to the fetus, including hypotension, irregular heart rate and fetal death from exanguination. If vasa previa is not diagnosed prior to labour and vaginal delivery, approximately 60% of newborns do not survive. Early diagnosis and institution of clear management plans that in part, include an elective caesarean delivery, is therefore imperative improving outcomes in this population. However, there is no consensus on the optimal methods for diagnosis and various aspects of suggested management. We aim to develop a core outcome set for studies on vasa previa. Our research questions are (1) What maternal, fetal, neonatal and obstetric outcomes have been reported in studies investigating the antenatal diagnosis and management of vasa previa in pregnant women? And (2) How have these reported outcomes been defined and/or measured?

Principal Investigator: Dr. Rohan D’Souza

Collaborators: Dr. John Kingdom, Dr. Nasrin Javid, Dr. Natasha Donnolley, Mike Krznaric

Funding: 

1. Perinatal Society of Australia and New Zealand
2. Internal Vasa Previa Foundation

Progress:

• Protocol – Published
• Phase 1 – Systematic Review – Published
• Phase 2 – Focus groups/individual interviews – completed
• Phase 3 – Delphi survey – completed
• Phase 4 – Consensus meeting – Late September 2022
• Phase 5 – Determination of outcome definition and measurement – TBA

Publications:

D’Souza R, Villani L, Hall C, Seyoum M, Kingdom J, Krznaric M, Donnolley N, Javid N. Core outcome set for studies on pregnant women with vasa previa (COVasP): a study protocol. BMJ Open. 2020 Jul 19;10(7):e034018. doi: 10.1136/bmjopen-2019-034018. PMID: 32690497; PMCID: PMC7371138.

Villani LA, Pavalagantharajah S, D’Souza R. Variations in reported outcomes in studies on vasa previa: a systematic review. Am J Obstet Gynecol MFM. 2020 Aug;2(3):100116. doi: 10.1016/j.ajogmf.2020.100116. Epub 2020 Apr 16. PMID: 33345867.

Project Description: Physiological changes inherently affecting the hematologic system during the perinatal period serve as a risk factor for the development of venous thromboembolism (VTE). VTE is one of the leading causes of maternal mortality, with the CDC reporting that pulmonary embolism (PE) accounted for 9.1% of maternal deaths between 2011-2014. In Canada, maternal deaths due to PE have been found to be under-reported. Furthermore, VTE is associated with long-term morbidity, with a proportion of women diagnosed with deep venous thrombosis (DVT) of the lower limbs developing long-term sequelae including leg edema, pain, and skin discolouration, commonly known as post-thrombotic syndrome (PTS). Numerous studies are currently exploring various aspects of perinatal VTE to inform future clinical practice, however the heterogeneity in outcome reporting limits the ability to compare outcomes across studies, and the lack of diversified stakeholder representation translates into potentially skewed outcome choices. A pragmatic solution to this challenge is the development of a core outcome set (COS) that defines the minimum criteria for outcome reporting in clinical trials and prospective studies undertaken in this population. The proposed systematic review, the first phase of COS development, aims to identify currently reported outcomes and methods used in their measurement.

Principal Investigator: Dr. Ann Kinga Malinowski

Collaborators: Dr. Rohan D’Souza, Alexandria King, Rachel Dadouch, Dylan Herman and Dr. Nadine Shehata

Funding: Canadian Graduate Student Scholarship awarded to Alexandria King

Progress: 

• Protocol – Published 
• Phase 1 – Systematic Review – in progress
• Phase 2 – Focus groups/individual interviews – Published
• Phase 3 – Delphi survey – Completed
• Phase 4 – Consensus meeting – TBA
• Phase 5 – Determination of outcome definition and measurement – TBA

Publications: 

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 Jul 19;10(7):e034017. doi: 10.1136/bmjopen-2019-034017. PMID: 32690496; PMCID: PMC7371150.

King A, Leider H, Herman D, Malinowski AK, D’Souza R. Patient- and Health-Care-Provider-Reported Outcomes to Consider in Research on Pregnancy-Associated Venous Thromboembolism. Thromb Haemost. 2021 Sep;121(9):1228-1236. doi: 10.1055/s-0041-1722855. Epub 2021 Feb 10. PMID: 33567461.

Project Description: The incidence of invasive placentation worldwide varies from 1.7 (95% CI 1.4-2.0) in the U.K. to 14.4 (95% CI 13.4-15.4) in Canada per 10,000 deliveries. Despite its rarity, it is significant as the incidence has risen dramatically in recent decades , from 1 in 4,027 pregnancies in the 1970s to 1 in 533 pregnancies in the 2000s, and will continue to rise, paralleling the increasing Caesarean delivery rates worldwide. Screening, diagnosing, and managing invasive placentation remains challenging, partially due to the many, often conflicting, outcomes reported in the literature. Prospective studies are necessary to address these knowledge gaps. In order for these studies to translate into improved patient care, and to meaningfully compare outcomes between studies, it is important to have a core set of outcomes considered important by patients and all other stakeholders involved in the care of these patients. The goal of this project is to develop a core outcome set for invasive placentation.

Principal Investigator: Dr. Rohan D’Souza

Collaborators: Susan O’Rinn, Dr. Jon Barrett, Dr. Janet Parsons, Dr. John Kingdom

Progress: 

• Protocol – Accepted
• Phase 1 – Systematic Review – TBA
• Phase 2 – Focus groups/individual interviews – TBA
• Phase 3 – Delphi survey – TBA
• Phase 4 – Consensus meeting – TBA
• Phase 5 – Determination of outcome definition and measurement – TBA

Publications: 

O’Rinn SE, Barrett JFR, Parsons J, Kingdom J, Kim L, & D’Souza R. Using the knowledge to action model to guide the development and dissemination of a core outcome set for studies on invasive placentation. COMET VII, Amsterdam, The Netherlands, 15 & 16 November 2018.

Project Description: Iron deficiency (ID) is the most common nutritional deficiency and the most common cause of anemia globally, affecting around two billion individuals, or over 30% of the population. ID accounts for almost 70% of anaemia in pregnancy. Adverse pregnancy outcomes believed to be associated with anemia include maternal and perinatal mortality, preterm birth, size small for gestational age. These adverse outcomes may extend into the postpartum period. Studies on the impact of IDA and iron supplementation on pregnancy outcomes have been limited by use of intermediary outcomes consisting of improvement of haematologic indices, at the expense of functional outcomes more reflective of clinical well-being. The objective of this project is to produce a core outcome set for studies focusing on the identification, assessment and management of iron deficiency anaemia in pregnancy and postpartum.

Principal Investigator: Dr. Ann Kinga Malinowski

Collaborators: Dr. Jahnavi Daru, Dr. Rohan D’Souza, Dr. Nadine Shehata and Dr. Khalid Khan

Progress: 

• Phase 1 – Systematic Review – Published
• Phase 2 – Focus groups/individual interviews – analysis ongoing
• Phase 3 – Delphi survey – TBA
• Phase 4 – Consensus meeting – TBA
• Phase 5 – Determination of outcome definition and measurement – TBA

Publications: 

Malinowski AK, D’Souza R, Khan KS, Shehata N, Malinowski M, Daru J. Reported Outcomes in Perinatal Iron Deficiency Anemia Trials: A Systematic Review. Gynecol Obstet Invest. 2019;84(5):417-434. doi: 10.1159/000495566. Epub 2019 Feb 1. PMID: 30712041.

Project Description: Critical illness during pregnancy poses specific challenges for the care of the affected women. Little good quality data exist to direct the assessment and management of these patients. Pregnant women have been largely excluded, or not specifically mentioned, in the large ICU studies addressing mechanical ventilation and septic shock. It is therefore important that future research efforts consist of multicentre studies with methodological rigor, focused on issues considered important by pregnant women, and using standardized outcomes deemed essential by all stakeholders. The COSCO (Core Outcome Set for studies on Critically ill Obstetric patients) study is the first step of a wide initiative to improve research on critical illness in pregnancy. It aims to develop a COS for research on critically ill obstetric patients.

Principal Investigator: Dr. Stephen Lapinsky

Collaborators: Dr. Julien Viau-Lapointe, Dr. Rohan D’Souza, Dr. Louise Rose, Dr. Julia Kfouri

Funding: ACCP (American College of Chest Physicians) Women’s Health Network Grant & The Lung Association: Ontario Grant-in-Aid

Learn more about this project here: http://www.icu-ob.org/cos-project/

Progress: 

• Protocol – Published
• Phase 1 – Systematic Review – completed
• Phase 2 – Focus groups/individual interviews – analysis ongoing
• Phase 3 – Delphi survey – NOW RECRUITING DELPHI PARTICIPANTS!
• Phase 4 – Consensus meeting – TBA
• Phase 5 – Determination of outcome definition and measurement – TBA

Publications: 

Viau-Lapointe J, D’Souza R, Rose L, Lapinsky SE. Development of a Core Outcome Set for research on critically ill obstetric patients: A study protocol. Obstet Med. 2018 Sep;11(3):132-136. doi: 10.1177/1753495X18772996. Epub 2018 May 14. PMID: 30214479; PMCID: PMC6134347.

Project Description: Sickle cell disease (SCD) is one of the most common hereditary hemoglobinopathies, accounting for approximately 28,600 deaths in 2010. Pregnancy in women with SCD is currently viewed more favorably; however, adverse pregnancy outcomes still occur, resulting in maternal or fetal morbidity and even mortality. Studies to date differ with respect to the outcomes they report, as do the definitions of these outcomes. This hampers the ability to compare, contrast, and combine these study results; a process particularly crucial in study areas, which focus on small populations, where the feasibility of accruing sample sizes necessary to properly power individual studies is sometimes an insurmountable challenge.

Principal Investigator: Dr. Ann Kinga Malinowski

Collaborators: Dr. Rohan D’Souza, Dr. Nadine Shehata, Dr. Richard Ward and Dr. Kevin Kuo

Progress: 

• Phase 1 – Systematic Review – TBA
• Phase 2 – Focus groups/individual interviews – TBA
• Phase 3 – Delphi survey – TBA
• Phase 4 – Consensus meeting – TBA
• Phase 5 – Determination of outcome definition and measurement – TBA

Project Description: Immune thrombocytopenia (ITP) is a clinical syndrome characterized by a low platelet count and increased risk of bleeding. It frequently occurs in women of childbearing age and is estimated to affect 1-10 of every 10,000 pregnancies. In pregnancy, platelet antibodies can cross the placenta resulting in neonatal thrombocytopenia. The literature to date contains studies that vary with regards to the reported outcomes and their measurement; limiting the ability to undertake rigorous meta-analysis that would enable extracting stronger conclusions, bolstered by larger sample sizes. Development of a core outcome set is the ideal solution to move forward research on this topic.

Principal Investigator: Dr. Ann Kinga Malinowski

Collaborators: Dr. Rohan D’Souza and Dr. Nadine Shehata

Progress: 

• Phase 1 – Systematic Review – TBA
• Phase 2 – Focus groups/individual interviews – TBA
• Phase 3 – Delphi survey – TBA
• Phase 4 – Consensus meeting – TBA
• Phase 5 – Determination of outcome definition and measurement – TBA

Project Description: Perinatology involve’s both the mother and the fetus, therefore studies in perinatology should examine both the mother and the fetus and the complex relationship that co-exists between them. Trials do so by using a “composite” to reflect both the maternal and fetal/neonatal adverse outcomes. HOWEVER – there is no standardization in regards to how these outcomes are defined and measured or which specific outcomes should constitute this composite. This study will address issues such as: irrelevancy of outcomes, researcher bias and lack of stakeholder involvement by developing a core outcome set (the minimum set of outcomes to be reported in future trials) with the involvement of stakeholders such as; patients, family members and professionals (physicians, nurses, researchers etc.).

Principal Investigator: Dr. Rohan D’Souza

Collaborators: Dylan Herman, Dr. Janet Parsons, Dr. Clara Juando-Prats and Dr. Pat O’Campo

Progress: 

• Phase 1 – Systematic Review – in progress
• Phase 2 – Focus groups/individual interviews – TBA
• Phase 3 – Delphi survey – TBA
• Phase 4 – Consensus meeting – TBA
• Phase 5 – Determination of outcome definition and measurement – TBA

Project Description: Seeking to improve outcome reporting in obstetric trials through ensuring comprehensive and transparent reporting. Our work will enable knowledge users to determine what outcomes a trial’s conclusions are based on; encourage trialists to consider patient-reported outcomes; and urge reviewers to include comprehensiveness of outcome reporting in the assessment of trial integrity.

Principle Investigator: Dr. Rohan D’Souza

Student Lead Investigator: Justin Lim

Progress:

• Developed and piloted an excel-based tool for assessing the comprehensiveness of outcome reporting (COR Tool) in obstetric trials. The COR Tool can be downloaded here.

Project Description: An attempt to standardize all stages of COS development in obstetric studies.

Principal Investigator: Dr. Rohan D’Souza

Collaborators: Justin Lim, Dr. Ann K Malinowski, Dr. John Kingdom, Dr. Rory Windrim

Progress: 

• Comprehensiveness of outcome reporting tool developed and validated
• Critical review of core outcome sets in obstetric studies ongoing