Obesity in Pregnancy – Patient-Reported Outcomes in Qualitative Research: A Systematic Review

Dadouch, Rachel; Hall, Chelsea; Mont, Janice Du; D’Souza, Rohan

doi:10.1016/j.jogc.2019.09.011

Cited by 16 publications

(23 citation statements)

References 43 publications

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“…Step II: Stakeholder interviews It is being increasingly recognized that conducting interviews with stakeholders identifies unique outcomes that are seldom, if at all, reported in trials [17]. Previous studies by the OROS group showed that although clinical outcomes and, to some extent, adverse events are adequately reported in the medical literature studies, the areas least represented include those related to functioning/life-impact and resource use [18]. Interviews with stakeholders provide the perfect opportunity to elicit outcomes related to these domains, to add to the list of (mostly clinical) outcomes obtained through systematic review.…”

Section: Analysis and Presentation Of Resultsmentioning

confidence: 99%

Development of a Core Outcome Set for Studies on Cardiac Disease in Pregnancy (COSCarP): a study protocol

D’Souza

Hall

Sermer

et al. 2020

Trials

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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.

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Section: Analysis and Presentation Of Resultsmentioning

confidence: 99%

Development of a Core Outcome Set for Studies on Cardiac Disease in Pregnancy (COSCarP): a study protocol

D’Souza

Hall

Sermer

et al. 2020

Trials

Self Cite

View full text Add to dashboard Cite

show abstract

“…1 This is also true of obstetric studies in cardiac disease and obesity, which often lack consideration of important patient-centric outcomes. 7,8 Clinical decisions made during pregnancy can have lifelong consequences for both mother and baby and it is thus particularly important that recommendations are based on outcomes appropriately chosen for the context. Despite this, researchers have drawn attention to a broad lack in reporting of fetal/neonatal outcomes 11,22 and, recently, to the importance of considering long-term maternal outcomes, such as cardiovascular mortality/morbidity resulting from prolonging pregnancies complicated by hypertensive disorders just to improve neonatal outcomes.…”

Section: Discussionmentioning

confidence: 99%

“…A systematic review analyzing 16 525 outcomes from 3515 Cochrane reviews, found 83% of reported outcomes were categorized as physiological, whereas only 24% measured functional impact and quality‐of‐life 1 . This is also true of obstetric studies in cardiac disease and obesity, which often lack consideration of important patient‐centric outcomes 7,8 …”

Section: Discussionmentioning

confidence: 99%

“…2 The systematic exclusion of some core outcome areas means findings may not fully represent outcomes that health-service users and healthcare providers would like clinical decisions to be based on, limiting clinical benefit and resulting in waste of funding. [3][4][5][6] Despite how pregnant women and their care providers frequently identify important outcomes as those related to life-impact, resource-use and adverse events, 7,8 these are seldomly reported in trials involving pregnancy. 9 There is preferential focus on mortality, physical morbidity and surrogate markers, failing to represent this complexity of patient care.…”

Section: Introductionmentioning

confidence: 99%

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A tool for assessing the comprehensiveness of outcome reporting within clinical trials in pregnancy

Lim

Lor

D’Souza

2021

Acta Obstet Gynecol Scand

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Introduction: Clinical trials provide fundamental evidence used to inform healthcare decisions at patient-and population levels and it is thus important that trials consider outcomes relevant to both patients and stakeholders. Although validated tools assessing other aspects of trial integrity exist, there is no tool for assessing the breadth and completeness of outcomes measured. Our objective was to develop a comprehensiveness of outcome reporting (COR) tool to assess this within trials in pregnancy. Material and methods:We developed a tool that aids in visualizing outcome reporting through the automatic generation of a heatmap, enabling assessment of the range of maternal and fetal/neonatal outcomes included in clinical trials. Outcome reporting and measurement of each study is compared to a context-specific, user-determined, ideal standard set of outcomes, created by initially considering all domains within five core outcome areas. These include mortality, morbidity, functioning/life-impact, resource-use, and adverse events, as identified by the most recent taxonomy for outcomes in medical research. We tested the tool's functionality using trials previously identified as studies on obesity in pregnant patients, and further compared the utility of the COR Tool against Cochrane's Risk of Bias 2.0 Tool using correlational analysis. Results:The pilot heatmap using clinical trials studying obesity in pregnancy (n = 15), illustrated a lack of comprehensiveness of reported outcomes in the majority of studies. Included trials were found to readily report physiological/clinical outcome but consistently neglected outcome areas related to functioning, delivery of care, resource-use, and adverse events. Outcome areas reported and measured were done so with largely varying degrees of quality. When the COR Tool was compared with Cochrane's RoB 2.0 Tool on a scatter plot, only a weak correlation was found (R = 0.2936, R 2 = 0.0862) Conclusions:The COR Tool will promote transparency in clarifying what outcomes a trial's conclusions are based on, encourage trialists to consider outcomes related to all aspects of maternal and fetal/neonatal health, and support reviewers in appraising outcome reporting and measurement in the assessment of trial integrity.

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“…This has been shown, for example, in work by Dadouch et al as part of their development of a core outcome set development for studies on obesity in pregnant patients, they found a lack of focus on neonatal outcomes and measures related to life impact such as physical or social functioning, wellbeing or quality of life (149) . Additionally, a review of qualitative research for obesity in pregnancy highlighted the importance placed on measures relating to life impact and delivery of care by women (150) . In other areas such as rheumatoid arthritis, fatigue was highlighted as an important outcome to patients and was subsequently included as a core outcome to measure in future trials (151) .…”

Section: Treatment Prioritisationmentioning

confidence: 99%

Addressing the gaps in nutritional care before and during pregnancy

et al. 2021

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The present paper outlines current issues in the nutritional care of women during pregnancy and potential resources to address them. Globally, overnutrition, undernutrition and nutritional imbalances are widespread among women of reproductive age; increasing the risk of pregnancy complications and non-communicable diseases in both mothers and their children. Most women do not meet dietary guidelines for pregnancy. The World Health Organisation (WHO) recommends nutrition and weight counselling during pregnancy for all women. However, clinical practices focusing on nutrition vary and there is no consensus on which outcomes are most important for pregnancy nutrition interventions, with little consideration for the ‘patient voice’. The International Federation of Gynaecology and Obstetrics (FIGO) nutrition checklist is a clinical practice tool that is available for healthcare professionals that will address this issue. The pregnancy nutrition core outcome set will also support advancement of antenatal nutrition by identifying the most critical nutrition-related outcomes from the perspective of healthcare professionals, researchers and women with experience of pregnancy. While poor nutrition can result in adverse outcomes across women of all weight categories, those with obesity may require specialist care to reduce their risk. Obesity is a chronic, progressive, relapsing disease that has high individual variability in its prognosis. The use of obesity staging systems, which consider mental, physical and functional health, can stratify individuals into risk categories and aid in treatment prioritisation in pregnancy. As the prevalence of obesity continues to rise, an obesity staging approach may support clinicians, especially those in limited resource settings.

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Obesity in Pregnancy – Patient-Reported Outcomes in Qualitative Research: A Systematic Review

Cited by 16 publications

References 43 publications

Development of a Core Outcome Set for Studies on Cardiac Disease in Pregnancy (COSCarP): a study protocol

Development of a Core Outcome Set for Studies on Cardiac Disease in Pregnancy (COSCarP): a study protocol

A tool for assessing the comprehensiveness of outcome reporting within clinical trials in pregnancy

Addressing the gaps in nutritional care before and during pregnancy

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