TMRP Webinar series 8: March 2024 - July 2024
All sessions included in series 8 of the Trials Methodology Research Partnership webinar series
Developing a Core Outcome Set for Neonatal Sepsis (NESCOS)
Wednesday 13 March 2024 - 11am-12pm
On behalf of the HRB TMRN
Our study, NESCOS (NEonatal Sepsis Core Outcome Set), was undertaken to develop a COS for studies evaluating the effectiveness of treatments for neonatal sepsis. The COS encompasses outcomes relevant to parents, families, caregivers, healthcare providers, policymakers, and researchers across all settings; including high-, middle-, and low-income countries. The webinar will summarise the stages of our COS development such as qualitative systematic review, Real-Time Delphi Survey and consensus meetings while also helping us share our experience with our colleagues. Presented by Dr Petek Eylül Taneri.
The ILANA study – using study recruitment targets to promote equity in clinical care for women, racially minoritised people and older people living with HIV in the UK
Wednesday 17 April 2024 - 11am-12pm
On behalf of the UKTMN
Rapid advances in HIV treatment over the last few decades have recently culminated in the development and approval of a novel, long-acting injectable therapy for HIV treatment. Long-acting Cabotegravir and Rilpivirine (CAB+RPV LA) allows people living with HIV to receive 2-monthly injectable treatment, rather than daily pills. However women, racially minoritised people and older people are chronically under-represented in HIV clinical trials. The ILANA implementation study, which explores the acceptability and feasibility of CAB+RPV LA delivered in clinical and community settings in England, provided an opportunity to promote inclusion in HIV research and equity in HIV clinical care through the use of study recruitment targets. In this talk, ILANA Trial Manager Nishat Halim and qualitative researcher Rosalie Hayes will discuss the thinking behind the study recruitment targets, how they worked in practice, and the impact they have had on the study findings so far.
Outcome reporting bias and SAPs in clinical trials
Wednesday 3 July 2024 - 1-2pm
On behalf of the MRC HTMR
Study publication bias and outcome reporting bias have been recognised as a potential threat to the validity of meta-analysis and can make the readily available evidence unreliable for decision making. Statistical Analysis Plans have the potential to reduce outcome reporting bias. In an update to a systematic review, we will summarise the evidence from cohort studies that have assessed study publication bias or outcome reporting bias in randomised controlled trials. Twenty-nine studies were eligible of which eleven were newly identified in this update. Eleven groups followed a cohort of trial through from protocol approval to information regarding publication of outcomes and investigated outcome reporting bias. Findings will be presented. Guidelines for the content of statistical analysis plans in clinical trials were published in 2018. An analysis of 62 citations in early 2020 revealed a steady increase in the use of the guidance. Findings from an updated analysis of a further 168 citations by the end of 2023 will be presented. The implications from contrasting the results from these two projects will be discussed.