Declan Devane

Developing core outcome sets for clinical trials: issues to consider

The selection of appropriate outcomes or domains is crucial when designing clinical trials in order to compare directly the effects of different interventions in ways that minimize bias. If the findings are to influence policy and practice then the chosen outcomes need to be relevant and important to key stakeholders including patients and the public, health care professionals and others making decisions about health care. There is a growing recognition that insufficient attention has been paid to the outcomes measured in clinical trials. These issues could be addressed through the development and use of an agreed standardized collection of outcomes, known as a core outcome set, which should be measured and reported, as a minimum, in all trials for a specific clinical area. Accumulating work in this area has identified the need for general guidance on the development of core outcome sets. Key issues to consider in the development of a core outcome set include its scope, the stakeholder groups to involve, choice of consensus method and the achievement of a consensus.

Methodology in conducting a systematic review of systematic reviews of healthcare interventions

BackgroundHundreds of studies of maternity care interventions have been published, too many for most people involved in providing maternity care to identify and consider when making decisions. It became apparent that systematic reviews of individual studies were required to appraise, summarise and bring together existing studies in a single place. However, decision makers are increasingly faced by a plethora of such reviews and these are likely to be of variable quality and scope, with more than one review of important topics. Systematic reviews (or overviews) of reviews are a logical and appropriate next step, allowing the findings of separate reviews to be compared and contrasted, providing clinical decision makers with the evidence they need.MethodsThe methods used to identify and appraise published and unpublished reviews systematically, drawing on our experiences and good practice in the conduct and reporting of systematic reviews are described. The process of identifying and appraising all published reviews allows researchers to describe the quality of this evidence base, summarise and compare the reviews conclusions and discuss the strength of these conclusions.ResultsMethodological challenges and possible solutions are described within the context of (i) sources, (ii) study selection, (iii) quality assessment (i.e. the extent of searching undertaken for the reviews, description of study selection and inclusion criteria, comparability of included studies, assessment of publication bias and assessment of heterogeneity), (iv) presentation of results, and (v) implications for practice and research.ConclusionConducting a systematic review of reviews highlights the usefulness of bringing together a summary of reviews in one place, where there is more than one review on an important topic. The methods described here should help clinicians to review and appraise published reviews systematically, and aid evidence-based clinical decision-making.

Increasing trends in atonic postpartum haemorrhage in Ireland: an 11‐year population‐based cohort study

Please cite this paper as: Lutomski J, Byrne B, Devane D, Greene R. Increasing trends in atonic postpartum haemorrhage in Ireland: an 11‐year population‐based cohort study. BJOG 2011; DOI: 10.1111/j.1471‐0528.2011.03198.x

Core Outcome Set–STAndards for Reporting: The COS-STAR Statement

Background Core outcome sets (COS) can enhance the relevance of research by ensuring that outcomes of importance to health service users and other people making choices about health care in a particular topic area are measured routinely. Over 200 COS to date have been developed, but the clarity of these reports is suboptimal. COS studies will not achieve their goal if reports of COS are not complete and transparent. Methods and Findings In recognition of these issues, an international group that included experienced COS developers, methodologists, journal editors, potential users of COS (clinical trialists, systematic reviewers, and clinical guideline developers), and patient representatives developed the Core Outcome Set–STAndards for Reporting (COS-STAR) Statement as a reporting guideline for COS studies. The developmental process consisted of an initial reporting item generation stage and a two-round Delphi survey involving nearly 200 participants representing key stakeholder groups, followed by a consensus meeting. The COS-STAR Statement consists of a checklist of 18 items considered essential for transparent and complete reporting in all COS studies. The checklist items focus on the introduction, methods, results, and discussion section of a manuscript describing the development of a particular COS. A limitation of the COS-STAR Statement is that it was developed without representative views of low- and middle-income countries. COS have equal relevance to studies conducted in these areas, and, subsequently, this guideline may need to evolve over time to encompass any additional challenges from developing COS in these areas. Conclusions With many ongoing COS studies underway, the COS-STAR Statement should be a helpful resource to improve the reporting of COS studies for the benefit of all COS users.

Discussions of findings from a Cochrane review of midwife-led versus other models of care for childbearing women: continuity, normality and safety

Health and Social Care Research Division, King’s College, London, UK Departement de Medecine Sociale et Preventive, Universite de Montreal, Montreal, Canada School of Nursing and Midwifery, Aras Moyola, National University of Ireland, Galway, Ireland Faculty of Health and Wellbeing, Sheffield Hallam University, Sheffield, UK Warwick Medical School Clinical Trials Unit, University of Warwick, Coventry, UK Corresponding author at: NIHR King’s Patient Safety and Service Quality Research Centre, Florence Nightingale School of Nursing and Midwifery, Waterloo Bridge Wing, 150 Stamford Street, King’s College, London SE1 9NH, UK. E-mail address: jane.sandall@kcl.ac.uk (J. Sandall).

A Metasynthesis of Midwife-Led Care

The purpose of this metasynthesis is to describe and interpret qualitative research relating to midwife-led care to see if it sheds light on why low-risk women experience fewer birth interventions within this model of care. Eleven articles were included in the review. Three themes emerged: (a) relationally mediated benefits for women that resulted in increased agency and empathic care; (b) the problematic interface of midwife-led units with host maternity units, stemming from a clash of models and culture; and (c) greater agency for midwives within midwife-led models of care though bounded by the relationship with the host maternity unit. This metasynthesis suggests that lower rates of interventions could be linked to the greater agency experienced by women and midwives within midwife-led models, and that these effects are mediated, in part, by the smallness of scale in these settings.

A systematic review and quality assessment of systematic reviews of randomised trials of interventions for preventing and treating preterm birth

The aim of this paper is to identify reviews of interventions for preventing and treating preterm birth so that these could be appraised and the findings from good quality reviews highlighted. Reviews, rather than individual studies, are the basis for this systematic review because of the proliferation of reviews and the benefits of a single, consistent appraisal and assessment of evidence from these reviews rather than further attempts to find and appraise the many individual studies in the literature. Our systematic review consists of a description of five interventions for preventing and treating preterm birth; antibiotics, cervical cerclage, bed rest, progesterone, and tocolytic therapy, for which at least one relevant review was found. The scope and quality of the identified reviews are described, and their conclusions and the strength of these conclusions discussed. Potentially eligible reviews were sought primarily through searches of the electronic databases MEDLINE (1966-2008), EMBASE (1980-2008), CINHAL (1982-2008), Science Citation Index (1970-2008) and The Cochrane Library (Issue 1, 2008). Thirty-seven reviews were identified of which 22 were included in this systematic review of reviews. This shows that antibiotics may significantly delay, but might not prevent, preterm birth for women with preterm prelabour rupture of membranes; there is insufficient evidence to show the absolute efficacy of cerclage and bed rest in preventing preterm birth; the use of progesterone appears promising; and the possible benefits of certain tocolytics, such as beta-mimetics, need to be reliably measured against the possible adverse effects when used in preventing preterm birth.

Making randomised trials more efficient: report of the first meeting to discuss the Trial Forge platform

Randomised trials are at the heart of evidence-based healthcare, but the methods and infrastructure for conducting these sometimes complex studies are largely evidence free. Trial Forge (www.trialforge.org) is an initiative that aims to increase the evidence base for trial decision making and, in doing so, to improve trial efficiency.This paper summarises a one-day workshop held in Edinburgh on 10 July 2014 to discuss Trial Forge and how to advance this initiative. We first outline the problem of inefficiency in randomised trials and go on to describe Trial Forge. We present participants’ views on the processes in the life of a randomised trial that should be covered by Trial Forge.General support existed at the workshop for the Trial Forge approach to increase the evidence base for making randomised trial decisions and for improving trial efficiency. Agreed upon key processes included choosing the right research question; logistical planning for delivery, training of staff, recruitment, and retention; data management and dissemination; and close down. The process of linking to existing initiatives where possible was considered crucial. Trial Forge will not be a guideline or a checklist but a ‘go to’ website for research on randomised trials methods, with a linked programme of applied methodology research, coupled to an effective evidence-dissemination process. Moreover, it will support an informal network of interested trialists who meet virtually (online) and occasionally in person to build capacity and knowledge in the design and conduct of efficient randomised trials.Some of the resources invested in randomised trials are wasted because of limited evidence upon which to base many aspects of design, conduct, analysis, and reporting of clinical trials. Trial Forge will help to address this lack of evidence.

COS-STAR: a reporting guideline for studies developing core outcome sets (protocol)

BackgroundCore outcome sets can increase the efficiency and value of research and, as a result, there are an increasing number of studies looking to develop core outcome sets (COS). However, the credibility of a COS depends on both the use of sound methodology in its development and clear and transparent reporting of the processes adopted. To date there is no reporting guideline for reporting COS studies. The aim of this programme of research is to develop a reporting guideline for studies developing COS and to highlight some of the important methodological considerations in the process.Methods/DesignThe study will include a reporting guideline item generation stage which will then be used in a Delphi study. The Delphi study is anticipated to include two rounds. The first round will ask stakeholders to score the items listed and to add any new items they think are relevant. In the second round of the process, participants will be shown the distribution of scores for all stakeholder groups separately and asked to re-score. A final consensus meeting will be held with an expert panel and stakeholder representatives to review the guideline item list. Following the consensus meeting, a reporting guideline will be drafted and review and testing will be undertaken until the guideline is finalised. The final outcome will be the COS-STAR (Core Outcome Set-STAndards for Reporting) guideline for studies developing COS and a supporting explanatory document.DiscussionTo assess the credibility and usefulness of a COS, readers of a COS development report need complete, clear and transparent information on its methodology and proposed core set of outcomes. The COS-STAR guideline will potentially benefit all stakeholders in COS development: COS developers, COS users, e.g. trialists and systematic reviewers, journal editors, policy-makers and patient groups.

Private health care coverage and increased risk of obstetric intervention

BackgroundWhen clinically indicated, common obstetric interventions can greatly improve maternal and neonatal outcomes. However, variation in intervention rates suggests that obstetric practice may not be solely driven by case criteria.MethodsDifferences in obstetric intervention rates by private and public status in Ireland were examined using nationally representative hospital discharge data. A retrospective cohort study was performed on childbirth hospitalisations occurring between 2005 and 2010. Multivariate logistic regression analysis with correction for the relative risk was conducted to determine the risk of obstetric intervention (caesarean delivery, operative vaginal delivery, induction of labour or episiotomy) by private or public status while adjusting for obstetric risk factors.Results403,642 childbirth hospitalisations were reviewed; approximately one-third of maternities (30.2%) were booked privately. After controlling for relevant obstetric risk factors, women with private coverage were more likely to have an elective caesarean delivery (RR: 1.48; 95% CI: 1.45-1.51), an emergency caesarean delivery (RR: 1.13; 95% CI: 1.12-1.16) and an operative vaginal delivery (RR: 1.25; 95% CI: 1.22-1.27). Compared to women with public coverage who had a vaginal delivery, women with private coverage were 40% more likely to have an episiotomy (RR: 1.40; 95% CI: 1.38-1.43).ConclusionsIrrespective of obstetric risk factors, women who opted for private maternity care were significantly more likely to have an obstetric intervention. To better understand both clinical and non-clinical dynamics, future studies of examining health care coverage status and obstetric intervention would ideally apply mixed-method techniques.