Declan Devane

• Ollscoil na Gaillimhe – University of Galway

Aims To investigate the cost‐effectiveness of early initiation of metformin and usual care for gestational diabetes mellitus (GDM). Methods Economic evaluation from a healthcare perspective, based on the EMERGE randomised controlled trial. In total, 535 women with GDM were randomised to placebo in addition to usual care or metformin in addition to...

Aim High‐impact infectious diseases pose major global health challenges, underscoring the urgent need for robust public health preparedness. Despite efforts to improve global health security, recent pandemics have revealed significant weaknesses in health systems’ preparedness and response capabilities. Methods We reviewed and synthesized key stra...

Health research increasingly incorporates public and patient involvement (PPI) to enhance trial inclusivity and relevance, and it is often mandated by funding and regulatory bodies. PPI boosts public engagement with trials and aligns trial objectives more closely with the priorities of the groups they aim to benefit. The Kid’s Trial, an online rand...

Background How, what and when infants are fed in the first year of life influences their health and development. Interventions to improve infant feeding demonstrate inconsistent findings, highlighting a need for standardisation of what and how outcomes are measured. A core outcome set of infant feeding outcomes for use in childhood obesity preventi...

This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the effectiveness of different SARS‐CoV‐2 testing strategies in reducing COVID‐19 cases, hospitalisations, and deaths among suspected cases and asymptomatic individuals.

Background The Rapid Evidence Support System Assessment (RESSA) was developed by the Global Evidence Commission to evaluate evidence support systems that inform policy decisions. These systems are designed to contextualize existing evidence, guide decision-making, and generate new insights to inform action. As evidence-informed policymaking gains t...

Importance Sepsis is one of the leading causes of neonatal mortality. There is heterogeneity in the outcomes measured and reported in studies of neonatal sepsis. To address this challenge, a core outcome set (COS) for research on neonatal sepsis was needed. Objective The Neonatal Sepsis Core Outcome Set (NESCOS) project aims to develop a COS for r...

Study objective Stillbirth is burdensome in low-income and middle-income countries (LMICs), especially in sub-Saharan Africa and South Asia. Currently, there are two core outcome sets (COS) for stillbirth (prevention and bereavement care), but these were developed with limited reflection of the needs of parents in an LMIC setting. To address this g...

Objective To establish whether digital foetal scalp stimulation (dFSS) performs better than foetal blood sampling (FBS) in terms of reducing the rate of caesarean section (CS) in labour, without adversely affecting perinatal outcomes. Design A multicentre parallel‐group randomised controlled trial. Setting Maternity centres in Ireland. Populatio...

Background The optimal approach to the diagnosis of atrial fibrillation in primary care is unclear. Aim To determine if external loop recorder (ELR) screening improves atrial fibrillation detection in community dwelling adults with a CHA2DS2-VASc score of greater than two. Design Randomised cross-over clinical trial. Methods Community dwelling a...

Pneumococcal infections are a serious health issue associated with increased morbidity and mortality. This systematic review evaluated the efficacy, effectiveness, immunogenicity, and safety of the pneumococcal conjugate vaccine (PCV)15 compared to other pneumococcal vaccines or no vaccination in children and adults. We identified 20 randomized con...

Background The COVID-19 pandemic marked a unique period characterised by an extraordinary global virus spread. The collective effort to halt the transmission of the virus led to various public health initiatives, including a variety of COVID-19 vaccine trials. Many of these trials used adaptive methods to address the pandemic’s challenges, such as...

Background The benefits of randomised trials are not shared equally, and people from ethnic minority groups are a key constituency under-served by clinical research and clinical care. The STRIDE project aimed to give trialists practical information about how to decide which ethnic groups should be in their trials, and at what proportion. Methods W...

The underrepresentation of equity, diversity, and inclusion (EDI) in health research limits the understanding of intervention impacts across diverse populations. This study aims to assess the extent of EDI consideration in SARS-CoV-2 testing strategy research and highlight the need for integrating these aspects into health research.

Background A dementia diagnosis can lead to a decline in cognitive, social, and physical health, but people with dementia can live meaningful lives and participate actively in society with psychosocial support. This single-arm, non-randomised feasibility study explored the feasibility and acceptability of a Comprehensive REsilience-building psychoS...

Background Neonatal encephalopathy (NE) is a multi-organ condition potentially leading to death or long-term neurodisability. Therapeutic hypothermia is the standard treatment for NE; however, long-term impairments remain common. Studies of new treatments for NE often measure and report different outcomes. Core outcome sets (COSs), a minimum set of...

Rapid reviews have gained popularity as a pragmatic approach to synthesise evidence in a timely manner to inform decision-making in healthcare. This article provides an overview of the key concepts and methodological considerations in conducting rapid reviews, drawing from a series of recently published guidance papers by the Cochrane Rapid Reviews...

Aims/hypothesis Gestational diabetes mellitus (GDM) is associated with adverse perinatal outcomes because of suboptimal glucose management and glucose control and excessive weight gain. Metformin can offset these factors but is associated with small for gestational age (SGA) infants. We sought to identify risk factors for SGA infants, including the...

( JAMA . 2023;330(16):1547–1556. doi: 10.1001/jama.2023.19869) Gestational diabetes (gDM) is a common pregnancy complication, affecting up to nearly 3 million pregnancies globally every year. It is known to be associated with adverse pregnancy outcomes, including weight gain, cesarean delivery, preeclampsia, birth injuries, respiratory distress, an...

Aim Women with gestational diabetes mellitus (GDM) display adverse lifetime cardiometabolic health. We examined whether early metformin in GDM could impact cardiometabolic risk factors postpartum. Methods EMERGE, a double-blind, placebo-controlled trial, randomized pregnancies 1:1 to placebo or metformin at GDM diagnosis and followed participants...

Randomised controlled trials often use surrogate endpoints to substitute for a target outcome (an outcome of direct interest and relevance to trial participants, clinicians, and other stakeholders—eg, all cause mortality) to improve efficiency (through shortened duration of follow-up, reduced sample size, and lower research costs), and for ethical...

Randomised controlled trials commonly use surrogate endpoints to substitute for a target outcome (outcome of direct interest and relevance to trial participants, clinicians, and other stakeholders—eg, all cause mortality) to improve their efficiency (through shorter trial duration, reduced sample size, and thus lower research costs), or for ethical...

Background ‘Neonatal encephalopathy’ (NE) describes a group of conditions in term infants presenting in the earliest days after birth with disturbed neurological function of cerebral origin. NE is aetiologically heterogenous; one cause is peripartum hypoxic ischaemia. Lack of uniformity in the terminology used to describe NE and its diagnostic crit...

Background Surgical handover is associated with a significant risk of care failures. Existing research displays methodological deficiencies and little consensus on the outcomes that should be used to evaluate interventions in this area. This paper reports a protocol to develop a core outcome set (COS) to support standardisation, comparability, and...

The 2022 Cochrane Lecture challenged Cochrane and its community to enhance their equity efforts and presented specific issues needing attention. We have created an actionable plan to address these challenges. These include: 1. Setting priorities for reviews based on health equity and global burden of disease 2. Advocate and support initiatives to p...

Background While a systematic review exists detailing neonatal sepsis outcomes from clinical trials, there remains an absence of a qualitative systematic review capturing the perspectives of key stakeholders. Objectives Our aim is to identify outcomes from qualitative research on any intervention to prevent or improve the outcomes of neonatal seps...

Objective The overabundance of health misinformation has undermined people's capacity to make evidence-based, informed choices about their health. Using the Informed Health Choices (IHC) Key Concepts (KCs), we are developing a two-stage education programme, Informed Health Choices-Cancer (IHC-C), to provide those impacted by cancer with the knowled...

Background Two core outcome sets for childhood obesity prevention have been developed; standardised sets of outcome measurement instruments for these core outcome sets are currently being developed. Core outcome sets and standardised measurement sets can reduce heterogeneity and improve evidence syntheses for trials of interventions to prevent chil...

Background Midwives are primary providers of care for childbearing women globally and there is a need to establish whether there are differences in effectiveness between midwife continuity of care models and other models of care. This is an update of a review published in 2016. Objectives To compare the effects of midwife continuity of care models...

(Abstracted from JAMA 2023;330(16):1547–1556 Worldwide, about 2.93 million pregnancies are complicated by gestational diabetes mellitus (GDM) annually. GDM is associated with an increased risk of maternal adverse outcomes, such as weight gain, cesarean delivery (CD), and preeclampsia, as well as fetal adverse outcomes, such as admission to the neon...

Background Evidence synthesis is used by decision-makers in various ways, such as developing evidence-based recommendations for clinical guidelines. Clinical guideline development groups (GDGs) typically discuss evidence synthesis findings in a multidisciplinary group, including patients, healthcare providers, policymakers, etc. A recent mixed meth...

This paper, part of the Cochrane Rapid Review Methods Group series, offers guidance on determining when to conduct a rapid review (RR) instead of a full systematic review (SR). While both review types aim to comprehensively synthesise evidence, RRs, conducted within a shorter time frame of typically 6 months or less, involve streamlined methods to...

Background Evidence to support decisions on trial processes is minimal. One way to generate this evidence is to use a Study Within A Trial (SWAT) to test trial processes or explore methodological uncertainties. SWAT evidence relies on replication to ensure sufficient power and broad applicability of findings. Prompt reporting is therefore essential...

Background Surgical handover is associated with a significant risk of care failures. Existing research displays methodological deficiencies and little consensus on the outcomes that should be used to evaluate interventions in this area This paper reports a protocol to develop a core outcome set (COS) to support standardisation, comparability, and e...

Background Randomised controlled trials (‘trials’) are susceptible to poor participant recruitment and retention. Studies Within A Trial are the strongest methods for testing the effectiveness of strategies to improve recruitment and retention. However, relatively few of these have been conducted. Objectives PROMoting THE Use of Studies Within A T...

Background: Evidence synthesis is used by decision-makers in various ways, such as developing evidence-based recommendations for clinical guidelines. Clinical guideline development groups (GDGs) typically discuss evidence synthesis findings in a multidisciplinary group, including patients, healthcare providers, policymakers, etc. A recent mixed met...

Neonatal sepsis is a serious public health problem; however, there is substantial heterogeneity in the outcomes measured and reported in research evaluating the effectiveness of the treatments. Therefore, we aim to develop a Core Outcome Set (COS) for studies evaluating the effectiveness of treatments for neonatal sepsis. Since a systematic review...

Introduction Rapid identification of severe acute respiratory syndrome‐coronavirus 2 (SARS‐CoV‐2) infections by testing potentially reduced coronavirus disease‐19 (COVID‐19) cases. Testing strategies varied across countries and during different stages of the pandemic. This scoping review aims to map the available evidence on the effectiveness of SA...

Background Suboptimal or slow recruitment affects 30–50% of trials. Education and training of trial recruiters has been identified as one strategy for potentially boosting recruitment to randomised controlled trials (hereafter referred to as trials). The Training tRial recruiters, An educational INtervention (TRAIN) project was established to devel...

Background Each journal metric has a one-of-a-kind algorithm with unique strengths and limitations. This study aims to explore the correlations among the journal metrics of the Public Health, Environmental, and Occupational Health (PHEOH) journals to help inform researchers’ decisions on their publications. Methods We included the first 300 journa...

Background Interventional trials that evaluate treatment effects using surrogate endpoints have become increasingly common. This paper describes four linked empirical studies and the development of a framework for defining, interpreting and reporting surrogate endpoints in trials.

Background Interventional trials that evaluate treatment effects using surrogate endpoints have become increasingly common. This paper describes four linked empirical studies and the development of a framework for defining, interpreting and reporting surrogate endpoints in trials. Methods As part of developing the CONSORT (Consolidated Standards o...

Background: Vaccination for coronavirus disease 2019 (COVID-19) has demonstrated reduced risk of hospitalisation and death against more recent variants of COVID-19. Some studies suggested improvements in patients with post-COVID-19 condition (PCC) following vaccination. We systematically explored available evidence on the effect of COVID-19 vaccine...

Importance Gestational diabetes is a common complication of pregnancy and the optimal management is uncertain. Objective To test whether early initiation of metformin reduces insulin initiation or improves fasting hyperglycemia at gestation weeks 32 or 38. Design, Setting, and Participants Double-blind, placebo-controlled trial conducted in 2 cen...

Supplementary document of the article titled "Effect of pharmacological interventions for the treatment of people with post‐COVID‐19 condition: A rapid review".

Background: The World Health Organization declared the COVID-19 pandemic on 11 March 2020. Vaccine development and deployment were swiftly prioritised as a method to manage and control disease spread. The development of an effective vaccine relies on people's participation in randomised trials. Recruitment to vaccine trials is particularly challen...

Background Delphi surveys are commonly used to prioritise critical outcomes in core outcome set (COS) development. This trial aims to compare a three-round (Multi-Round) Delphi (MRD) with a Real-Time Delphi (RTD) in the prioritisation of outcomes for inclusion in a COS for neonatal encephalopathy treatments and explore whether ‘feedback’, ‘iteratio...

Objective This study aimed to create core outcome sets (COSs) for use in research studies relating to the awareness and clinical management of reduced fetal movement (RFM). Design Delphi survey and consensus process. Setting International. Population A total of 128 participants (40 parents, 19 researchers and 65 clinicians) from 16 countries. M...

Background: It has been reported that people with COVID-19 and pre-existing autoantibodies against type I interferons are likely to develop an inflammatory cytokine storm responsible for severe respiratory symptoms. Since interleukin 6 (IL-6) is one of the cytokines released during this inflammatory process, IL-6 blocking agents have been used for...

Background Paediatric trials must contend with many challenges that adult trials face but often bring additional obstacles. Decentralised trials, where some or all trial methods occur away from a centralised location, are a promising strategy to help meet these challenges. This scoping review aims to (a) identify what methods and tools have been us...

Background Public and patient involvement aims to improve research quality, relevance, and appropriateness. Despite an increasing evidence base on the influence of public involvement in health research, the role of involvement in methodology research (i.e. research that aims to enhance the quality and rigour of research) is less clear. Using a qual...

Objectives We aimed to develop a video animation knowledge translation (KT) resource to explain the purpose, use and importance of evidence synthesis to the public regarding healthcare decision-making. Methods We drew on a user-centred design approach to develop a spoken animated video (SAV) by conducting two cycles of idea generation, prototyping...

This paper is part of a series of methodological guidance from the Cochrane Rapid Reviews Methods Group. Rapid reviews (RRs) use modified systematic review methods to accelerate the review process while maintaining systematic, transparent and reproducible methods. This paper addresses considerations for rating the certainty of evidence (COE) in RRs...

This paper is part of a series of methodological guidance from the Cochrane Rapid Reviews Methods Group. Rapid reviews (RR) use modified systematic review methods to accelerate the review process while maintaining systematic, transparent and reproducible methods. In this paper, we address considerations for RR searches. We cover the main areas rele...

This paper is part of a series of methodological guidance from the Cochrane Rapid Reviews Methods Group (RRMG). Rapid reviews (RRs) use modified systematic review (SR) methods to accelerate the review process while maintaining systematic, transparent and reproducible methods to ensure integrity. This paper addresses considerations around the accele...

Objective Little is known about the treatment of post‐coronavirus disease 2019 (COVID‐19) condition (PCC). This article examines the effectiveness of pharmacological interventions for treating people with PCC. Methods We searched Medline, EMBASE, ClinicalTrials. gov, and the International Clinical Trials Registry Platform. Two independent review a...

Objective: Assess the impact of the Health Research Board (HRB) Ireland guidance on the uptake of core outcome sets (COS). Study design and setting: 1. Information on COS use, searching of the Core Outcome Measures in Effectiveness Trials (COMET) database and rationale for outcome selection were extracted from HRB funding applications 2. COMET w...

Objectives: Limited research on using smart wearables such as Fitbit devices among people with dementia has shown favourable outcomes. The aim of this study was to explore the acceptability and feasibility of using a Fitbit Charge 3 among people with dementia, living in the community, who took part in the physical exercise component of the Compreh...

Background: Paediatric trials must contend with many challenges that adult trials face but often bring additional obstacles. Decentralised trials, where some or all trial methods occur away from a centralised location, are a promising strategy to help meet these challenges. This scoping review aims to (a) identify what methods and tools have been u...

Background: Continuous fetal heart rate monitoring by cardiotocography (CTG) is used in labour for women with complicated pregnancies. Fetal heart rate abnormalities are common and may result in the decision to expedite delivery by caesarean section. Fetal scalp stimulation (FSS) is a second-line test of fetal well-being that may provide reassuran...

Introduction: The health of women in rural communities is adversely impacted by increased rates of tobacco use linked to socio-economic disadvantage (SED) and by limited access to services. We Can Quit (WCQ) is a smoking cessation programme delivered by trained lay women (community facilitators) in local communities, which was developed using a Co...

Background: Uncomplicated urinary tract infections (UTIs) are among the most common presentations of bacterial infections in the outpatient setting. The variation of outcomes reported in trials to assess the most effective treatment interventions for uncomplicated UTIs has meant that comparing and synthesising the outcomes across trials is challeng...

Well-conducted systematic reviews and other evidence syntheses are important in informing policy and practice decisions. It is reasonable to expect that the processes by which reviews are planned, conducted, analysed and reported are informed by up-to-date research evidence. However, many of the decisions taken when ‘doing’ systematic reviews and o...

Background: Different forms of vaccines have been developed to prevent the SARS-CoV-2 virus and subsequent COVID-19 disease. Several are in widespread use globally. OBJECTIVES: To assess the efficacy and safety of COVID-19 vaccines (as a full primary vaccination series or a booster dose) against SARS-CoV-2. Search methods: We searched the Cochra...

Background: Public and patient involvement aims to improve research quality, relevance, and appropriateness. Despite an increasing evidence base on the influence of public involvement in health research, the role of involvement in methodology research, i.e., how we plan, do, and share research, is less clear. Using a qualitative case study, we expl...

Introduction Clinical guideline development often involves a rigorous synthesis of evidence involving multidisciplinary stakeholders with different priorities and knowledge of evidence synthesis; this makes communicating findings complex. Summary formats are typically used to communicate the results of evidence syntheses; however, there is little c...

Objectives: This is a protocol for a Cochrane Review (intervention). The objectives are as follows:. The aim of this review is to determine the effectiveness of knowledge translation interventions for facilitating evidence-informed decision-making amongst health policymakers. Copyright © 2022 The Cochrane Collaboration. Published by John Wiley & So...

Background Cardiotocography (CTG) is a screening test used to detect fetal hypoxia in labour. It has a high false positive rate resulting in many potentially unnecessary caesarean sections. Fetal blood sampling (FBS) is a second-line test of the acid-base status of the fetus. It is used to provide either reassurance that it is safe for labour to co...

The population prevalence of recurrent miscarriage (RM) is 1–3%, depending on the definition used, i.e. 2 or ≥3 miscarriages. There are uncertainties around how to organise RM care, including debates relating to the investigations and treatments that should be provided. Standardised care pathways tailored to women/couples who experience RM are need...

Abstract Background Pregnancies affected by gestational diabetes mellitus (GDM) are associated with an increased risk of adverse maternal and foetal outcomes. Current treatments for GDM involve initial medical nutritional therapy (MNT) and exercise and pharmacotherapy in those with persistent hyperglycaemia. Insulin is considered first-line pharmac...

Randomised trials, especially those intended to directly inform clinical practice and policy, should be designed to reflect all those who could benefit from the intervention under test should it prove effective. This does not always happen. The UK National Institute for Health and Care Research (NIHR) INCLUDE project identified many groups in the U...

Background: Few areas of health have been as insidiously influenced by misinformation as cancer. Thus, interventions that can help people impacted by cancer reduce the extent to which they are victims of misinformation are necessary. The Informed Health Choices (IHC) initiative has developed Key Concepts that can be used in the development of inter...

Objectives: A rapid review is a form of evidence synthesis considered a resource-efficient alternative to the conventional systematic review. Despite a dramatic rise in the number of rapid reviews commissioned and conducted in response to the coronavirus disease 2019 pandemic, published evidence on the optimal methods of planning, doing, and shari...

Background: The population prevalence of recurrent miscarriage is 1–3%, depending on the definition used (two or three miscarriages). There are uncertainties around how to organise RM care, including debates about appropriate investigations and treatments. Clinical practice can be inconsistent and poorly organised. Standardised care pathways tailor...

Introduction: This scoping review will determine how online, randomised trials with children are conducted. The objectives of the review are: (a) to determine what methods and tools have been used to create and conduct online trials with children and (b) to identify the gaps in the knowledge in this field. Over the last decade, randomised trials em...

Objective To test the feasibility of undertaking a simultaneous Study Within A Trial (SWAT) to train staff who recruit participants into surgical randomised controlled trials (RCTs), by assessing key uncertainties around recruitment, randomisation, intervention delivery and data collection. Study design and setting Twelve surgical RCTs were eligib...

Objectives: Standardised care pathways tailored to the needs of women/couples who experience recurrent miscarriage are needed; however, clinical practice can be inconsistent and poorly organised. While there are European/international guidelines, there is currently no clinical guideline for recurrent miscarriage care in Ireland, nor has the current...

Objectives: Standardised care pathways tailored to the needs of women/couples who experience recurrent miscarriage are needed; however, clinical practice can be inconsistent and poorly organised. While there are European/international guidelines, there is currently no clinical guideline for recurrent miscarriage care in Ireland, nor has the current...

Introduction The PROMETHEUS programme (PROMoting THE USE of SWATs) was funded by the UK Medical Research Council (MRC) and Clinical Trials Unit (CTU) infrastructure funding from the National Institute for Health Research (NIHR). The purpose was to develop strategies to increase the recruitment and retention evidence base. This paper aims to present...

Plain English summary Women/couples who have recurrent/repeated miscarriages should receive care that meets their needs, through agreed care pathways. This is often not the case. Key performance indicators (KPIs) are measures of specific elements of care (structures, processes and/or outcomes), which can help us to judge the quality of care given....

Introduction : Clinical guideline development often involves a rigorous synthesis of evidence involving multidisciplinary stakeholders with different priorities and knowledge of evidence synthesis; this makes communicating findings complex. Summary formats are typically used to communicate the results of evidence syntheses, however, there is little...

Introduction : Evidence syntheses, often in the form of systematic reviews, are essential for clinical guideline development and informing changes to health policies. However, clinical guideline development groups (CGDG) are multidisciplinary, and participants such as policymakers, healthcare professionals and patient representatives can face obsta...

Introduction This scoping review will determine how online, randomised trials with children are conducted. The objectives of the review are: (a) to determine what methods and tools have been used to create and conduct online trials with children and (b) to identify the gaps in the knowledge in this field. Over the last decade, randomised trials emp...