scholarly journals Pharmacoepidemiology in pregnancy: analysis protocol for an observational cohort study in the UK Clinical Practice Research Datalink

2022 ◽  
Vol 7 ◽  
pp. 12
Author(s):  
Ciarrah-Jane Barry ◽  
Christy Burden ◽  
Neil Davies ◽  
Venexia Walker
Keyword(s):  
Cohort Study ◽  
Clinical Practice ◽  
Drug Exposure ◽  
Negative Control ◽  
Practice Research ◽  
Clinical Practice Research Datalink ◽  
Control Analysis ◽  
Definitive Evidence ◽  
Using Data ◽  
The Uk

Large numbers of women take prescription and over-the-counter medications during pregnancy. However, there is very little definitive evidence about the potential effects of these drugs on the mothers and offspring. We will investigate the risks and benefits of continuing prescriptive drug use for chronic pre-existing maternal conditions such as diabetes, hypertension and thyroid related conditions throughout pregnancy. If left untreated, these conditions are established risk factors for adverse neonatal and maternal outcomes. However, some treatments for these conditions are associated with adverse neonatal outcomes. Our primary aims are twofold. Firstly, we aim to estimate the beneficial effect on the mother of continuing treatment during pregnancy. Second, we aim to determine whether there is an associated detrimental impact on the neonate of continuation of maternal treatment during pregnancy. To establish this evidence, we will investigate the relationship between maternal drug prescriptions and adverse and beneficial offspring outcomes to provide evidence to guide clinical decisions. We will conduct a hypothesis testing observational intergenerational cohort study using data from the UK Clinical Practice Research Datalink (CPRD). We will apply four statistical methods: multivariable adjusted regression, propensity score regression, instrumental variables analysis and negative control analysis. These methods should account for potential confounding when estimating the association between the drug exposure and maternal or neonatal outcome. In this protocol we describe the aims, motivation, study design, cohort and statistical analyses of our study to aid reproducibility and transparency within research.

scholarly journals Examining the risk of depression or self-harm associated with incretin-based therapies used to manage hyperglycaemia in patients with type 2 diabetes: a cohort study using the UK Clinical Practice Research Datalink

BMJ Open ◽  
2018 ◽  
Vol 8 (10) ◽  
pp. e023830 ◽  
Author(s):  
John-Michael Gamble ◽  
Eugene Chibrikov ◽  
William K Midodzi ◽  
Laurie K Twells ◽  
Sumit R Majumdar
Keyword(s):  
Cohort Study ◽  
Clinical Practice ◽  
Population Based ◽  
Practice Research ◽  
Primary Study ◽  
Clinical Practice Research Datalink ◽  
Glucose Lowering ◽  
Self Harm ◽  
The Uk ◽  
New Onset

ObjectivesTo compare population-based incidence rates of new-onset depression or self-harm in patients initiating incretin-based therapies with that of sulfonylureas (SU) and other glucose-lowering agents.DesignPopulation-based cohort study.SettingPatients attending primary care practices registered with the UK-based Clinical Practice Research Datalink (CPRD).ParticipantsUsing the UK-based CPRD, we identified two incretin-based therapies cohorts: (1) dipeptidyl peptidase-4 inhibitor (DPP-4i)-cohort, consisting of new users of DPP-4i and SU and (2) glucagon-like peptide-1 receptor agonists (GLP-1RA)-cohort, consisting of new users of GLP-1RA and SU, between January 2007 and January 2016. Patients with a prior history of depression, self-harm and other serious psychiatric conditions were excluded.Main outcome measuresThe primary study outcome comprised a composite of new-onset depression or self-harm. Unadjusted and adjusted Cox proportional hazards regression was used to quantify the association between incretin-based therapies and depression or self-harm. Deciles of High-Dimensional Propensity Scores and concurrent number of glucose-lowering agents were used to adjust for potential confounding.ResultsWe identified new users of 6206 DPP-4i and 22 128 SU in the DPP-4i-cohort, and 501 GLP-1RA and 16 409 SU new users in the GLP-1RA-cohort. The incidence of depression or self-harm was 8.2 vs 11.7 events/1000 person-years in the DPP-4i-cohort and 18.2 vs 13.6 events/1000 person-years in the GLP-1RA-cohort for incretin-based therapies versus SU, respectively. Incretin-based therapies were not associated with an increased or decreased incidence of depression or self-harm compared with SU (DPP-4i-cohort: unadjusted HR 0.70, 95% CI 0.51 to 0.96; adjusted HR 0.80, 95% CI 0.57 to 1.13; GLP-1RA-cohort: unadjusted HR 1.36, 95% CI 0.72 to 2.58; adjusted HR 1.25, 95% CI 0.63 to 2.50). Consistent results were observed for other glucose-lowering comparators including insulin and thiazolidinediones.ConclusionsOur findings suggest that the two incretin-based therapies are not associated with an increased or decreased risk of depression or self-harm.

scholarly journals Health of mothers of children with a life-limiting condition: a protocol for comparative cohort study using the Clinical Practice Research Datalink

BMJ Open ◽  
2020 ◽  
Vol 10 (7) ◽  
pp. e034024
Author(s):  
Lorna Katharine Fraser ◽  
Fliss E M Murtagh ◽  
Trevor Sheldon ◽  
Simon Gilbody ◽  
Catherine Hewitt
Keyword(s):  
Cohort Study ◽  
Clinical Practice ◽  
Well Being ◽  
Research Centre ◽  
Practice Research ◽  
Clinical Practice Research Datalink ◽  
Comparative Cohort Study ◽  
Limiting Condition ◽  
The Uk ◽  
The Impact

IntroductionThere are now nearly 50 000 children with a life-limiting or life-threatening condition in the UK. These include conditions where there is no reasonable hope of cure and from which they will die, as well as conditions for which curative treatment may be feasible but can fail, for example, cancer or heart failure. Having a child with a life-limiting condition involves being a coordinator and provider of healthcare in addition to the responsibilities and pressures of parenting a child who is expected to die young. This adversely affects the health and well-being of these mothers and affects their ability to care for their child, but the extent of the impact is poorly understood.This study aims to quantify the incidence and nature of mental and physical morbidity in mothers of children with a life-limiting condition, their healthcare use and to assess whether there is a relationship between the health of the mother and the child’s condition.Methods and analysisA comparative cohort study using data from the Clinical Practice Research Datalink and linked hospital data will include three groups of children and their mothers (those with a life-limiting condition, those with a chronic condition and those with no long-term health condition total=20 000 mother–child dyads). Incidence rates and incidence rate ratios will be used to quantify and compare the outcomes between groups with multivariable regression modelling used to assess the relationship between the child’s disease trajectory and mother’s health.Ethics and disseminationThis study protocol has approval from the Independent Scientific Advisory Committee for the UK Medicines and Healthcare products Regulatory Agency Database Research. The results of this study will be reported according to the STROBE and RECORD guidelines. There will also be a lay summary for parents which will be available to download from the Martin House Research Centre website (www.york.ac.uk/mhrc).

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