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Article ; Online: Opening Windows Behind Closed Doors

Pauline Meskell / Catherine Houghton / Linda Biesty

International Journal of Qualitative Methods, Vol

Reflections on Working Qualitatively During a Pandemic

2021 Volume 20

Keywords	Social sciences (General) ; H1-99
Language	English
Publishing date	2021-03-01T00:00:00Z
Publisher	SAGE Publishing
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Recruiters' perspectives of recruiting women during pregnancy and childbirth to clinical trials

Vivienne Hanrahan / Katie Gillies / Linda Biesty

PLoS ONE, Vol 15, Iss 6, p e

A qualitative evidence synthesis.

2020 Volume 0234783

Abstract: Introduction Research on research is key to enhancing efficacy in trial methodology. Clinical trials involving women during pregnancy and childbirth are limited, with a paucity of data guiding evidence-based practice. Following a prioritisation exercise ... ...

Abstract	Introduction Research on research is key to enhancing efficacy in trial methodology. Clinical trials involving women during pregnancy and childbirth are limited, with a paucity of data guiding evidence-based practice. Following a prioritisation exercise that highlighted the top-ten unanswered recruitment questions, this qualitative evidence synthesis was designed specifically to focus on the barriers and enablers for clinicians/healthcare professionals in helping conduct randomised trials within the context of recruitment during pregnancy and childbirth. Methods The synthesis was undertaken using Thomas and Harden's three stage thematic synthesis method and reported following the ENTREQ guidelines. Using a pre-determined SPIDER strategy, we conducted a comprehensive search of databases; Pubmed, CINAHL, PsycINFO, EMBASE, and grey searches for records until January 2019. We included all reports of qualitative data on recruiter's experiences, perceptions, views of recruiting women during pregnancy and childbirth to clinical trials. Altogether 13,401 records were screened, resulting in 31 full-text reviews, of which five were eligible for inclusion. Quality was appraised using CASP. Data were extracted onto a specifically defined form. We used thematic synthesis to identify descriptive and analytical themes, and to interpret and generate theory. Confidence was assessed using GRADE-CERQual. The review protocol is publicly available (OSF https://osf.io/g4dt9/). Results Five papers (representing four individual studies) from two different countries were included. All studies focused on the experiences of trial recruiters in the maternity setting. We identified four analytical themes; Recruitment through a clinician's lens, Recruiters judgement on acceptability, From protocol to recruiters lived experience, Framing recruitment in context. These were linked by an overarching theme combining beliefs and power. Conclusion The overarching theme combining beliefs and power links the experiences and perceptions of recruiters. ...
Keywords	Medicine ; R ; Science ; Q
Subject code	610
Language	English
Publishing date	2020-01-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Can learning about trials be child’s play? A qualitative exploration of the ‘Schools Teaching Awareness of Randomised Trials’ (START) initiative

Linda Biesty / Sandra Galvin / Elaine Finucane / Patricia Healy / Declan Devane / Tom Conway

Trials, Vol 21, Iss 1, Pp 1-

2020 Volume 12

Abstract: Abstract Background The Health Research Board-Trials Methodology Research Network (HRB-TMRN) celebrates International Clinical Trials Day with the help of the younger members of our community through the Network’s ‘Schools Teaching Awareness of ... ...

Abstract	Abstract Background The Health Research Board-Trials Methodology Research Network (HRB-TMRN) celebrates International Clinical Trials Day with the help of the younger members of our community through the Network’s ‘Schools Teaching Awareness of Randomised Trials (START)’ initiative. START seeks to increase public awareness of randomised trials in Ireland. Launched in 2016, it asks children (8–12 years old) to conduct and report their very own fun randomised trial. The study reported in this paper sought to explore children and teachers perceptions and experiences of the START initiative. Methods We conducted eight, one-to one interviews with teachers and eight focus groups with 61 children who took part in the 2018 START initiative. Interviews and focus groups were recorded and transcribed and the data analysed using template analysis. Results The findings of this study highlight the benefits of participating in START and the areas of the initiative that required further attention. Teachers and children recalled the benefits of experiential learning associated with START and learning by doing encouraged a fun way of engaging with trial processes. By recalling all aspects of planning, conducting and reporting their trial, the children in this study demonstrated their awareness of the trial processes. The teachers suggested that START provides a valuable framework to contribute to key aspects of the primary school curriculum in Ireland. The experiences of these participants also provided recommendation for improving the programme for future START participants. Conclusions Increasing public awareness and understanding of randomised trials can help increase public engagement in trials. By educating children about the importance of trials and supporting them to ‘learn by doing’ by carrying out their own trial, the START initiative can contribute substantially to children’s awareness and understanding of trial processes. Given that children are the public, the patients and the researchers of the future, initiatives ...
Keywords	Trials ; RCTs ; Methodological research ; Qualitative research ; Medicine (General) ; R5-920
Subject code	370
Language	English
Publishing date	2020-02-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Qualitative data sharing practices in clinical trials in the UK and Ireland

Katie Gillies / Julia Wade / Nikki Rousseau / Linda Biesty / Carrol Gamble / Val Bryant / Catherine Houghton / Matthew Sydes / Megan McCarthy / Maura Dowling / Elaine Toomey / Karen Matvienko-Sikar

HRB Open Research, Vol

towards the production of good practice guidance [version 1; peer review: 2 approved]

2023 Volume 6

Abstract: Background: Data sharing enables researchers to conduct novel research with previously collected datasets, thus maximising scientific findings and cost effectiveness, and reducing research waste. The value of sharing, even de-identified, quantitative ... ...

Abstract	Background: Data sharing enables researchers to conduct novel research with previously collected datasets, thus maximising scientific findings and cost effectiveness, and reducing research waste. The value of sharing, even de-identified, quantitative data from clinical trials is well recognised with a moderated access approach recommended. While substantial challenges to sharing quantitative data remain, there are additional challenges for sharing qualitative data in trials. Incorporating the necessary information about how qualitative data will be shared into already complex trial recruitment and consent processes proves challenging. The aim of this study was to explore whether and how trial teams share qualitative data collected as part of the design, conduct, analysis, or delivery of clinical trials. Methods: Phase 1 involved semi-structured, in-depth qualitative interviews and focus groups with key trial stakeholder groups including trial managers and clinical trialists (n=3), qualitative researchers in trials (n=9), members of research funding bodies (n=2) and trial participants (n=1). Data were analysed using thematic analysis. In Phase 2, we conducted a content analysis of 16 participant information leaflets (PIL) and consent forms (CF) for trials that collected qualitative data. Results: Three key themes were identified from our Phase 1 findings: ‘Understanding and experiences of the potential benefits of sharing qualitative data from trials’, ‘Concerns about qualitative data sharing’, and ‘Future guidance and funding’. In phase 2, the PILs and CFs received revealed that the benefits of data sharing for participants were only explained in two of the study documents. Conclusions: The value of sharing qualitative data was acknowledged, but there are many uncertainties as to how, when, and where to share this data. In addition, there were ethical concerns in relation to the consent process required for qualitative data sharing in trials. This study provides insight into the existing practice of qualitative ...
Keywords	qualitative ; data sharing ; trials ; focus groups ; eng ; Medicine ; R
Subject code	306
Language	English
Publishing date	2023-02-01T00:00:00Z
Publisher	F1000 Research Ltd
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: A QuESt for speed

Linda Biesty / Pauline Meskell / Claire Glenton / Hannah Delaney / Mike Smalle / Andrew Booth / Xin Hui S. Chan / Declan Devane / Catherine Houghton

Systematic Reviews, Vol 9, Iss 1, Pp 1-

rapid qualitative evidence syntheses as a response to the COVID-19 pandemic

2020 Volume 6

Abstract: Abstract Background The COVID-19 pandemic has created a sense of urgency in the research community in their bid to contribute to the evidence required for healthcare policy decisions. With such urgency, researchers experience methodological challenges to ...

Abstract	Abstract Background The COVID-19 pandemic has created a sense of urgency in the research community in their bid to contribute to the evidence required for healthcare policy decisions. With such urgency, researchers experience methodological challenges to maintain the rigour and transparency of their work. With this in mind, we offer reflections on our recent experience of undertaking a rapid Cochrane qualitative evidence synthesis (QES). Methods This process paper, using a reflexive approach, describes a rapid QES prepared during, and in response to, the COVID-19 pandemic. Findings This paper reports the methodological decisions we made and the process we undertook. We place our decisions in the context of guidance offered in relation to rapid reviews and previously conducted QESs. We highlight some of the challenges we encountered in finding the balance between the time needed for thoughtfulness and comprehensiveness whilst providing a rapid response to an urgent request for evidence. Conclusion The need for more guidance on rapid QES remains, but such guidance needs to be based on actual worked examples and case studies. This paper and the reflections offered may provide a useful framework for others to use and further develop.
Keywords	Rapid reviews ; Qualitative evidence synthesis ; Review methods ; Systematic review ; COVID-19 ; Medicine ; R
Subject code	306
Language	English
Publishing date	2020-11-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Metabolic follow-up at one year and beyond of women with gestational diabetes treated with insulin and/or oral hypoglycaemic agents

Delia Bogdanet / Aoife Egan / Narjes Fhelelboom / Linda Biesty / Shakila Thangaratinam / Eugene Dempsey / Caroline Crowther / Declan Devane / Fidelma Dunne

Trials, Vol 20, Iss 1, Pp 1-

study protocol for the identification of a core outcomes set using a Delphi survey

2019 Volume 7

Abstract: Abstract Background Gestational diabetes (GDM) is associated with an increased lifetime risk for the development of glucose abnormalities, metabolic syndrome, cardiovascular disease, depression and tumours. Despite this high risk of additional ... ...

Abstract	Abstract Background Gestational diabetes (GDM) is associated with an increased lifetime risk for the development of glucose abnormalities, metabolic syndrome, cardiovascular disease, depression and tumours. Despite this high risk of additional comorbidities, there is no standardised approach to the long-term follow-up of women with a previous diagnosis of GDM. Also, there is no standardisation of outcome selection and reporting in studies involving this population. This increases the risk of reporting bias and reduces the possibility of meaningful comparisons between studies. The aim of this study is to develop a protocol for a core outcome set (COS) for the metabolic follow-up at 1 year and beyond of women with previous GDM treated with insulin and/or oral hypoglycaemic agents. Methods/design This protocol will describe the steps that will be taken in order to develop the COS. The study will consist of three parts: (1) A systematic review of the literature of the outcomes reported in previous randomised controlled trials of the follow-up at 1 year and beyond of women with GDM treated with insulin and/or oral hypoglycaemic agents; (2) A three-round, online Delphi survey with key stakeholders in order to prioritise these outcomes; and (3) A consensus meeting where the final COS will be decided. Discussion The proposed protocol is the first step in developing a COS that will bring consistency and uniformity to outcome selection and reporting in GDM women treated with insulin and/or oral hypoglycaemic agents.
Keywords	Core outcome set ; Gestational diabetes ; Insulin ; Oral hypoglycaemic agents ; Medicine (General) ; R5-920
Language	English
Publishing date	2019-01-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Feasibility study protocol of a pragmatic, randomised controlled pilot trial

Elaine M. Finucane / Linda Biesty / Deirdre Murphy / Amanda Cotter / Eleanor Molloy / Martin O’Donnell / Shaun Treweek / Paddy Gillespie / Marian Campbell / John J. Morrison / Alberto Alvarez-Iglesias / Gill Gyte / Declan Devane

Trials, Vol 22, Iss 1, Pp 1-

membrane sweeping to prevent post-term pregnancy—the MILO Study

2021 Volume 15

Abstract: Abstract Background Post-term pregnancy is associated with an increased risk of maternal complications, respiratory distress and trauma to the neonate. Amniotic membrane sweeping has been recommended as a simple procedure to promote the spontaneous onset ...

Abstract	Abstract Background Post-term pregnancy is associated with an increased risk of maternal complications, respiratory distress and trauma to the neonate. Amniotic membrane sweeping has been recommended as a simple procedure to promote the spontaneous onset of labour. However, despite its widespread use, there is an absence of evidence on (a) its effectiveness and (b) its optimal timing and frequency. The primary aim of the MILO Study is to inform the optimal design of a future definitive randomised trial to evaluate the effectiveness (including optimal timing and frequency) of membrane sweeping to prevent post-term pregnancy. We will also assess the acceptability and feasibility of the proposed trial interventions to clinicians and women (through focus group interviews). Methods/design Multicentre, pragmatic, parallel-group, pilot randomised controlled trial with an embedded factorial design. Pregnant women with a live, singleton foetus ≥ 38 weeks gestation; cephalic presentation; longitudinal lie; intact membranes; English speaking and ≥ 18 years of age will be randomised in a 2:1 ratio to membrane sweep versus no membrane sweep. Women allocated randomly to a sweep will then be randomised further (factorial component) to early (from 39 weeks) versus late (from 40 weeks) sweep commencement and a single versus weekly sweep. The proposed feasibility study consists of four work packages, i.e. (1) a multicentre, pilot randomised trial; (2) a health economic analysis; (3) a qualitative study; and (4) a study within the host trial (a SWAT). Outcomes to be collected include recruitment and retention rates, compliance with protocol, randomisation and allocation processes, attrition rates and cost-effectiveness. Focus groups will be held with women and clinicians to explore the acceptability and feasibility of the proposed intervention, study procedures and perceived barriers and enablers to recruitment. Discussion The primary aim of the MILO Study is to inform the optimal design of a future definitive randomised trial to ...
Keywords	Feasibility ; Pilot trial ; SWAT ; Induction of labour ; Membrane sweep ; Post-term ; Medicine (General) ; R5-920
Subject code	420
Language	English
Publishing date	2021-02-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: The People’s Trial

Elaine Finucane / Ann O’Brien / Shaun Treweek / John Newell / Kishor Das / Sarah Chapman / Paul Wicks / Sandra Galvin / Patricia Healy / Linda Biesty / Katie Gillies / Anna Noel-Storr / Heidi Gardner / Mary Frances O’Reilly / Declan Devane

Trials, Vol 23, Iss 1, Pp 1-

supporting the public’s understanding of randomised trials

2022 Volume 12

Abstract: Abstract Background Randomised trials are considered the gold standard in providing robust evidence on the effectiveness of interventions. However, there are relatively few initiatives to help increase public understanding of what randomised trials are ... ...

Abstract	Abstract Background Randomised trials are considered the gold standard in providing robust evidence on the effectiveness of interventions. However, there are relatively few initiatives to help increase public understanding of what randomised trials are and why they are important. This limits the overall acceptance of and public participation in clinical trials. The People’s Trial aims to help the public learn about randomised trials, to understand why they matter, and to be better equipped to think critically about health claims by actively involving them in all aspects of trial design. This was done by involving the public in the design, conduct, and dissemination of a randomised trial. Methods Using a reflexive approach, we describe the processes of development, conduct, and dissemination of The People’s Trial. Results Over 3000 members of the public, from 72 countries, participated in The People’s Trial. Through a series of online surveys, the public designed a trial called The Reading Trial. They chose the question the trial would try to answer and decided the components of the trial question. In December 2019, 991 participants were recruited to a trial to answer the question identified and prioritised by the public, i.e. ‘Does reading a book in bed make a difference to sleep in comparison with not reading a book in bed?’ We report the processes of The People’s Trial in seven phases, paralleling the steps of a randomised trial, i.e. question identification and prioritisation, recruitment, randomisation, trial conduct, data analysis, and sharing of findings. We describe the decisions we made, the processes we used, the challenges we encountered, and the lessons we learned. Conclusion The People’s Trial involved the public successfully in the design, conduct, and dissemination of a randomised trial demonstrating the potential for such initiatives to help the public learn about randomised trials, to understand why they matter, and to be better equipped to think critically about health claims. Trial registration ...
Keywords	Randomised trial ; Public engagement ; Online ; Methodology ; Medicine (General) ; R5-920
Subject code	028
Language	English
Publishing date	2022-03-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Risk of bias assessment of sequence generation

Francesca Wuytack / Maria Regan / Linda Biesty / Pauline Meskell / Jennifer E. Lutomski / Martin O’Donnell / Shaun Treweek / Declan Devane

Systematic Reviews, Vol 8, Iss 1, Pp 1-

a study of 100 systematic reviews of trials

2019 Volume 8

Abstract: Abstract Background Systematic reviews of randomised trials guide policy and healthcare decisions. Yet, we observed that some reviews judge randomised trials as high or unclear risk of bias (ROB) for sequence generation, potentially introducing bias. ... ...

Abstract	Abstract Background Systematic reviews of randomised trials guide policy and healthcare decisions. Yet, we observed that some reviews judge randomised trials as high or unclear risk of bias (ROB) for sequence generation, potentially introducing bias. However, to date, the extent of this issue has not been well examined. We evaluated the consistency in the ROB assessment for sequence generation of randomised trials in Cochrane and non-Cochrane reviews, and explored the reviewers’ judgement of the quality of evidence for the related outcomes. Methods Cochrane intervention reviews (01/01/2017–31/03/2017) were retrieved from the Cochrane Database of Systematic Reviews. We also searched for systematic reviews in ten general medical journals with highest impact factors (01/01/2016–31/03/2017). We examined the proportion of reviews that rated the sequence generation domain as high, low or unclear risk of selection bias. For reviews that had rated any randomised trials as high or unclear risk of bias, we examined the proportion that had assessed the quality of evidence. Results Overall, 100 systematic reviews were included in our analysis. We evaluated 64 Cochrane reviews which comprised of 984 randomised trials; 0.8% (n = 8) and 52.2% (n = 514) were rated as high and unclear ROB for sequence generation respectively. We further evaluated 36 non-Cochrane reviews which comprised of 1376 trials; 5.8% (n = 80) and 39.6% (n = 545) were rated as high and unclear ROB respectively. Ninety percent (n = 10) of non-Cochrane reviews which rated randomised trials as high ROB for sequence generation did not report an underlying reason. All Cochrane reviews assessed the quality of evidence (GRADE). For the non-Cochrane reviews, only just over half had assessed the quality of evidence. Conclusion Systematic reviews of interventions frequently rate randomised trials as high or unclear ROB for sequence generation. In general, Cochrane reviews were more transparent than non-Cochrane reviews in ROB and quality of evidence assessment. The ...
Keywords	Randomisation ; Sequence generation ; Systematic reviews ; Risk of bias ; Quality of evidence ; Medicine ; R
Subject code	610
Language	English
Publishing date	2019-01-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Multi-Round compared to Real-Time Delphi for consensus in core outcome set (COS) development

Fiona A. Quirke / Patricia Healy / Elaine Ní Bhraonáin / Mandy Daly / Linda Biesty / Tim Hurley / Karen Walker / Shireen Meher / David M. Haas / Frank H. Bloomfield / Jamie J. Kirkham / Eleanor J. Molloy / Declan Devane

Trials, Vol 22, Iss 1, Pp 1-

a randomised trial

2021 Volume 9

Abstract: Abstract Background The Delphi method is used in a wide variety of settings as a method of building consensus on important issues. Traditionally, the Delphi method uses multiple rounds of a survey to allow for feedback of other participants’ survey ... ...

Abstract	Abstract Background The Delphi method is used in a wide variety of settings as a method of building consensus on important issues. Traditionally, the Delphi method uses multiple rounds of a survey to allow for feedback of other participants’ survey responses in between rounds. By informing participants about how others answer a question or prioritise specific topics, it allows for diverse opinions to inform the consensus process. For this reason, the Delphi method is popular as a consensus building approach in developing core outcome sets (COS), i.e. the minimum agreed set of standardised outcomes that should be measured and reported in studies on a specific health condition. In a COS setting, participants prioritise the importance of outcomes for inclusion in a COS. This usually involves participating in multiple rounds of a survey that can span several weeks or months. Challenges with participant retention have been highlighted in previous COS. We will compare a three-round with a Real-Time Delphi approach on prioritised outcomes. This trial is embedded within the COHESION study which is developing a COS for interventions treating neonatal encephalopathy. Methods One hundred and eighty stakeholders (parents/caregivers of infants diagnosed and treated with neonatal encephalopathy, healthcare providers and researchers) will be randomised using stratified randomisation to take part in either the Multi-Round or Real-Time Delphi. Stakeholders will rate the importance of the same set of outcomes in both arms. We will compare the prioritised outcomes at the end of both surveys as well as other parameters such as feedback, initial condition and iteration effects. Discussion This trial will provide evidence to inform decisions on the use of Multi-Round compared to Real-Time Delphi survey methods. Trial registration NCT04471103 . Registered on 14 July 2020.
Keywords	Real-Time Delphi ; Multi-Round Delphi ; Core outcome sets ; Methodology ; Randomised trial ; Medicine (General) ; R5-920
Language	English
Publishing date	2021-02-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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