ORCID Profile
0000-0002-6496-4859
Current Organisation
University of Oxford
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Publisher: Elsevier BV
Date: 2019
DOI: 10.1016/J.AJOG.2018.09.023
Abstract: Clinical research should ultimately improve patient care. To enable this, randomized controlled trials must select, collect, and report outcomes that are both relevant to clinical practice and genuinely reflect the perspectives of key stakeholders including health care professionals, researchers, and patients. Unfortunately, many randomized controlled trials fall short of this requirement. Complex issues, including a failure to take into account the perspectives of key stakeholders when selecting outcomes, variations in outcome definitions and measurement instruments, and outcome reporting bias make research evidence difficult to interpret, undermining the translation of research into clinical practice. Problems with poor outcome selection, measurement, and reporting can be addressed by developing, disseminating, and implementing core outcome sets. A core outcome set represents a minimum data set of outcomes developed using robust consensus science methods engaging erse stakeholders including health care professionals, researchers, and patients. Core outcomes should be routinely utilized by researchers, collected in a standardized manner, and reported consistently in the final publication. They are currently being developed across our specialty including infertility, endometriosis, and preecl sia. Recognizing poorly selected, collected, and reported outcomes as serious hindrances to progress in our specialty, more than 80 journals including the Journal, have come together to support the Core Outcomes in Women's and Newborn Health (CROWN) initiative. The consortium supports researchers to develop, disseminate, and implement core outcome sets. Implementing core outcome sets could make a profound contribution to addressing poorly selected, collected, and reported outcomes. Implementation should ensure future randomized controlled trials hold the necessary reach and relevance to inform clinical practice, enhance patient care, and improve patient outcomes.
Publisher: Elsevier BV
Date: 10-2016
DOI: 10.1016/J.PREGHY.2016.04.008
Abstract: Pre-ecl sia is a serious complication of pregnancy and contributes to maternal and offspring mortality and morbidity. Randomised controlled trials evaluating therapeutic interventions for pre-ecl sia have reported many different outcomes and outcome measures. Such variation contributes to an inability to compare, contrast, and combine in idual studies, limiting the usefulness of research to inform clinical practice. The development and use of a core outcome set would help to address these issues ensuring outcomes important to all stakeholders, including patients, will be collected and reported in a standardised fashion. An international steering group including healthcare professionals, researchers, and patients, has been formed to guide the development of this core outcome set. Potential outcomes will be identified through a comprehensive literature review and semi-structured interviews with patients. Potential core outcomes will be entered into an international, multi-perspective online Delphi survey. All key stakeholders, including healthcare professionals, researchers, and patients will be invited to participate. The modified Delphi method encourages whole and stakeholder group convergence towards consensus 'core' outcomes. Once core outcomes have been agreed upon it is important to determine how they should be measured. The truth, discrimination, and feasibility assessment framework will assess the quality of potential outcome measures. High quality outcome measures will be associated with core outcomes. Mechanisms exist to disseminate and implement the resulting core outcome set within an international context. Embedding the core outcome set within future clinical trials, systematic reviews, and clinical practice guidelines could make a profound contribution to advancing the usefulness of research to inform clinical practice, enhance patient care, and improve maternal and offspring outcomes. The infrastructure created by developing a core outcome set for pre-ecl sia could be leveraged in other settings, for ex le selecting research priorities and clinical practice guideline development. PROSPECTIVE REGISTRATION: [1] Core Outcome Measures in Effectiveness Trials (COMET) registration number: 588. [2] International Prospective Register of Systematic Reviews (PROSPERO) registration number: CRD42015015529.
Publisher: Wiley
Date: 19-12-2017
Abstract: Randomised trials and their syntheses in meta-analyses offer a unique opportunity to assess the frequency and severity of adverse reactions. To assess safety reporting in pre-ecl sia trials. Systematic search using bibliographic databases, including Cochrane Central Register of Controlled Trials, Embase, and MEDLINE, from inception to August 2017. Randomised trials evaluating anticonvulsant or antihypertensive medication for pre-ecl sia. Descriptive statistics appraising the adequacy of adverse reaction and toxicity reporting. We included 60 randomised trials. Six trials (10%) were registered with the International Clinical Trials Registry Platform, two registry records referred to adverse reactions, stating 'safety and toleration' and 'possible side effects' would be collected. Twenty-six trials (43%) stated the frequency of withdrawals within each study arm, and five trials (8%) adequately reported these withdrawals. Adverse reactions were inconsistently reported across eligible trials: 24 (40%) reported no serious adverse reactions and 36 (60%) reported no mild adverse reactions. The methods of definition or measurement of adverse reactions were infrequently reported within published trial reports. Pre-ecl sia trials regularly omit critical information related to safety. Despite the paucity of reporting, randomised trials collect an enormous amount of safety data. Developing and implementing a minimum data set could help to improve safety reporting, permitting a more balanced assessment of interventions by considering the trade-off between the benefits and harms. National Institute for Health Research (DRF-2014-07-051), UK Maternity Forum, Royal Society of Medicine, UK. Developing @coreoutcomes could help to improve safety reporting in #preecl sia trials. @NIHR_DC.
Publisher: Public Library of Science (PLoS)
Date: 05-12-2014
Publisher: Wiley
Date: 14-06-2017
Abstract: Standardising outcome collection and reporting in pre-ecl sia trials requires an appraisal of current outcome reporting. To map maternal and offspring outcome reporting across randomised trials evaluating therapeutic interventions for pre-ecl sia. Randomised trials were identified by searching bibliographical databases from inception to January 2016. Randomised controlled trials. We systematically extracted and categorised outcome reporting. Seventy-nine randomised trials, reporting data from 31 615 maternal participants and 28 172 of their offspring, were included. Fifty-five different interventions were evaluated. Included trials reported 119 different outcomes, including 72 maternal outcomes and 47 offspring outcomes. Maternal outcomes were inconsistently reported across included trials for ex le, 11 trials (14%) reported maternal mortality, reporting data from 12 422 participants, and 16 trials (20%) reported cardiovascular morbidity, reporting data from 14 963 maternal participants. Forty-three trials (54%) reported fetal outcomes and 23 trials (29%) reported neonatal outcomes. Twenty-eight trials (35%) reported offspring mortality. There was poor reporting of childhood outcomes: six trials (8%) reported neurodevelopmental outcomes. Less than half of included trials reported any relevant information regarding harms for maternal participants and their offspring. Most randomised trials evaluating interventions for pre-ecl sia are missing information on clinically important outcomes, and in particular have neglected to evaluate efficacy and safety in the offspring of participants. Developing and implementing a minimum data set, known as a core outcome set, in future pre-ecl sia trials could help to address these issues. Future #preecl sia research requires a core outcome set to reduce #research waste. @coreoutcomes @jamesmnduffy International Prospective Register of Systematic Reviews: CRD42015015529 www.crd.york.ac.uk/PROSPERO/display_record.aspID=CRD42015015529.
Publisher: SAGE Publications
Date: 07-08-2012
Publisher: Wiley
Date: 07-09-2017
DOI: 10.1002/IJGO.12298
Abstract: An evaluation of outcome reporting is required to develop a core outcome set. To assess primary outcomes and outcome measure reporting in pre-ecl sia trials. Five online databases were searched from inception to January 2016 using terms including "preecl sia" and "randomized controlled trial". Randomized controlled trials evaluating treatments for pre-ecl sia published in any language were included. Primary outcomes and data on outcome measure reporting were systematically extracted and categorized. Overall, 79 randomized trials including data from 31 615 women were included. Of those, 38 (48%) reported 35 different primary outcomes 28 were maternal outcomes and seven were fetal/neonatal outcomes. Three randomized trials reported composite outcomes, incorporating between six and nine outcome components. The method of definition or measurement was infrequently or poorly reported. Even when outcomes were consistent across trials, different methods of definition or measurement were frequently described. In randomized trials evaluating interventions for pre-ecl sia, critical information related to the primary outcome, including definition and measurement, is regularly omitted. Developing a core outcome set for pre-ecl sia trials would help to inform primary outcome selection and outcome measure reporting.
Publisher: SAGE Publications
Date: 11-2019
Abstract: Australia and the United Kingdom have introduced policies to protect employees who experience mental illness, including depression. However, a better understanding of the experiential issues workers face (e.g. sense of moral failure) is needed for the provision of appropriate and beneficial support. We analysed 73 interviews from the United Kingdom and Australia where narratives of depression and work intersected. Participants encountered difficulties in being (and performing as if) ‘authentic’ at work, with depression contributing to confusions about the self. The diffuse post-1960s imperative to ‘be yourself’ is experienced in conflicting ways: while some participants sought support from managers and colleagues (e.g. sick leave, back-to-work plans), many others put on a façade in an attempt to perform the ‘well’ and ‘authentic’ employee. We outline the contradictory forces at play for participants when authenticity and visibility are expected, yet, moral imperatives to be good (healthy) employees are normative.
Publisher: SAGE Publications
Date: 05-10-2010
Abstract: This study investigated whether the Communication Checklist — Adult (CC-A) could identify subtypes of social and communication dysfunction in autism probands and their parents. The CC-A is ided into subscales measuring linguistic ability as well as two aspects of social communication: the Pragmatic Skills subscale assesses the level of pragmatic oddities (e.g. excessive talking), while the Social Engagement subscale picks up on those behaviours that reflect a more passive communication style (e.g. failure to engage in social interactions). CC-A data were collected for 69 autism probands, 238 parents of autism probands and 187 typical participants. The CC-A proved sensitive to the communication difficulties of autism probands and a proportion of their parents. The majority of parents who demonstrated the broader phenotype scored poorly on either the Pragmatic Skills or Social Engagement scale only. The Social Engagement scale was particularly sensitive to the difficulties of the parents, indicating that social-communicative passivity may be an important part of the broader autism phenotype. The findings provide evidence for the existence of more constrained pragmatic phenotypes in autism. Molecular genetic studies in this area may benefit from stratifying s les according to these phenotypes.
Publisher: Wiley
Date: 05-09-2019
Abstract: To quantify the effect of different methodological decisions on the identification of potential core outcomes to inform the development of recommendations for future core coutcome set developers. Mixed methods study. A core outcome set for pre-ecl sia was used as an exemplar. A long list of potential core outcomes was developed by undertaking a systematic review of pre-ecl sia trials and performing a thematic analysis of in-depth patient interviews. Specific methods used to generate long lists of potential core outcomes were evaluated. Different methodological decisions had a substantial impact on the identification of potential core outcomes. Extracting outcomes from published pre-ecl sia trials was an effective way of identifying 48 maternal, eight fetal, 25 neonatal outcomes, and eight patient-reported outcomes. Limiting the extraction of outcomes to primary outcomes or outcomes commonly reported in pre-ecl sia trials reduced the number and ersity of potential core outcomes identified. Thematic analysis of in-depth patient interviews ensured an additional five patient reported outcomes and six outcomes related to future child health were identified. Future core outcome set developers should use quantitative and qualitative methods when developing a long list of potential core outcomes. TWEETABLE ABSTRACT: @OfficialNIHR research published in @BJOGtweets informs new recommendations for future @coreoutcomes developers.
Publisher: Wiley
Date: 21-08-2017
Abstract: Variation in outcome collection and reporting is a serious hindrance to progress in our specialty therefore, over 80 journals have come together to support the development, dissemination, and implementation of core outcome sets. This study systematically reviewed and characterised registered, progressing, or completed core outcome sets relevant to women's and newborn health. Systematic search using the Core Outcome Measures in Effectiveness Trial initiative and the Core Outcomes in Women's and Newborn Health initiative databases. Registry entries, protocols, systematic reviews, and core outcome sets. Descriptive statistics to describe characteristics and results. There were 49 core outcome sets registered in maternal and newborn health, with the majority registered in 2015 (n = 22 48%) or 2016 (n = 16 32%). Benign gynaecology (n = 8 16%) and newborn health (n = 3 6%) are currently under-represented. Twenty-four (52%) core outcome sets were funded by international (n = 1 <1%), national (n = 18 38%), and regional (n = 4 8%) bodies. Seven protocols were published. Twenty systematic reviews have characterised the inconsistency in outcome reporting across a broad range of relevant healthcare conditions. Four core outcome sets were completed: reconstructive breast surgery (11 outcomes), preterm birth (13 outcomes), epilepsy in pregnancy (29 outcomes), and maternity care (48 outcomes). The quantitative, qualitative, and consensus methods used to develop core outcome sets varied considerably. Core outcome sets are currently being developed across women's and newborn health, although coverage of topics is variable. Development of further infrastructure to develop, disseminate, and implement core outcome sets is urgently required. Forty-nine women's and newborn core outcome sets registered. 50% funded. 7 protocols, 20 systematic reviews, and 4 core outcome sets published. @coreoutcomes @jamesmnduffy.
Publisher: BMJ
Date: 10-02-2016
DOI: 10.1136/BMJ.I563
Location: United Kingdom of Great Britain and Northern Ireland
Start Date: 2009
End Date: 2011
Funder: Australian Research Council
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