Cohort studies generate and collect longitudinal data for a variety of research purposes. Randomised controlled trials (RCTs) increasingly use cohort studies as data infrastructures to help identify and recruit trial participants and assess outcomes.
To examine the extent, range and nature of research using cohorts for RCTs and describe the varied definitions and conceptual boundaries for RCTs using cohorts.
Scoping review.
Searches were undertaken in January 2021 in MEDLINE (Ovid) and EBM Reviews—Cochrane Methodology Registry (Final issue, third Quarter 2012).
Reports published between January 2007 and December 2021 of (a) cohorts used or planned to be used, to conduct RCTs, or (b) RCTs which use cohorts to recruit participants and/or collect trial outcomes, or (c) methodological studies discussing the use of cohorts for RCTs.
Data were extracted on the condition being studied, age group, setting, country/continent, intervention(s) and comparators planned or received, unit of randomisation, timing of randomisation, approach to informed consent, study design and terminology.
A total of 175 full-text articles were assessed for eligibility. We identified 61 protocols, 9 descriptions of stand-alone cohorts intended to be used for future RCTs, 39 RCTs using cohorts and 34 methodological papers.
The use and scope of this approach is growing. The thematics of study are far-ranging, including population health, oncology, mental and behavioural disorders, and musculoskeletal conditions.
Authors reported that this approach can lead to more efficient recruitment, more representative samples, and lessen disappointment bias and crossovers.
This review outlines the development of cohorts to conduct RCTs including the range of use and innovative changes and adaptations. Inconsistencies in the use of terminology and concepts are highlighted. Guidance now needs to be developed to support the design and reporting of RCTs conducted using cohorts.
Pre-eclampsia is a hypertensive disorder affecting up to 8% of pregnancies. After pre-eclampsia, women are at increased risk of cognitive problems, and cerebrovascular and cardiovascular disorders. These sequelae could result from microvascular dysfunction persisting after pre-eclampsia. This study will explore differences in cerebral and myocardial microvascular function between women after pre-eclampsia and women after normotensive gestation. We hypothesise that pre-eclampsia alters cerebral and myocardial microvascular functions, which in turn are related to diminished cognitive and cardiac performance.
The cross-sectional ‘DEcreased Cognitive functiON, NEurovascular CorrelaTes and myocardial changes in women with a history of pre-eclampsia’ (DECONNECT) pilot study includes women after pre-eclampsia and controls after normotensive pregnancy between 6 months and 20 years after gestation. We recruit women from the Queen of Hearts study, a study investigating subclinical heart failure after pre-eclampsia. Neuropsychological tests are employed to assess different cognitive domains, including attention, processing speed, and cognitive control. Cerebral images are recorded using a 7 Tesla MRI to assess blood–brain barrier integrity, perfusion, blood flow, functional and structural networks, and anatomical dimensions. Cardiac images are recorded using a 3 Tesla MRI to assess cardiac perfusion, strain, dimensions, mass, and degree of fibrosis. We assess the effect of a history of pre-eclampsia using multivariable regression analyses.
This study is approved by the Ethics Committee of Maastricht University Medical Centre (METC azM/UM, NL47252.068.14). Knowledge dissemination will include scientific publications, presentations at conferences and public forums, and social media.
To explore the experiences and consequences of bariatric surgery stigma from the perspective of bariatric surgery patients and to identify knowledge gaps in the literature.
A scoping review.
Studies published between December 2002 and January 2022 were identified from the following databases: PubMed, Web of Science, PsycINFO and MEDLINE.
We screened 3092 records and included 28 studies. Findings were grouped thematically using the health stigma discrimination framework.
Patients experienced several types of stigmas, including perceived, experienced, anticipated and internalized stigma, related to undergoing bariatric surgery. Patients were confronted with negative comments and judgement from others when they disclosed their decision to have surgery or when they revealed that they had undergone surgery. These experiences led to conflicts in the decision-making process, such as delaying the choice for surgery, seeking surgery abroad or opting out. Patients who internalized stigma often reported feelings of shame and embarrassment for choosing surgery and felt the need for secrecy or selective disclosure. Stigma experiences were influenced by gender and differed between different subgroups of patients.
The stigma surrounding bariatric surgery has detrimental consequences for eligible individuals and bariatric surgery patients. However, the evidence from patients' perspective remains limited. More research into patient's experiences is needed to improve patient care and further educate healthcare professionals. In addition, to better understand the nature and implications of bariatric surgery stigma, future research should be founded on stigma theories and distinguish between the different types of stigmas.
This scoping review contributes to a better understanding of the implications the stigma surrounding bariatric surgery has for bariatric surgery patients before and after surgery. The knowledge generated by this review can inform improvements in the education and management of people living with obesity and bariatric surgery patients.
The scoping review adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Extension for Scoping Reviews checklist.
No Patient or Public Contribution.
A protocol was not registered for this scoping review.