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Article ; Online: Stakeholders’ perspectives and experiences of patient and public involvement (PPI) in clinical trials in maternal and neonatal healthcare

Déirdre Daly / Kathleen Hannon / Valerie Smith / Jessica Eustace-Cook

HRB Open Research, Vol

protocol for a qualitative evidence synthesis [version 2; peer review: 2 approved]

2023 Volume 6

Abstract: Background: Patient and public involvement (PPI) has the potential to improve the relevance of trial outcomes and improve participant recruitment within clinical trials. However, the literature on PPI approaches, outcomes, and attitudes towards PPI in ... ...

Abstract	Background: Patient and public involvement (PPI) has the potential to improve the relevance of trial outcomes and improve participant recruitment within clinical trials. However, the literature on PPI approaches, outcomes, and attitudes towards PPI in specific clinical research areas is limited. We are interested to know the current approaches to and views of PPI within maternal and neonatal clinical trials, from the perspective and experience of involved stakeholders. Methods: A qualitative evidence synthesis (QES) of stakeholders’ perspectives and experiences of PPI will be conducted. Stakeholders will include any individual involved in maternal or neonatal clinical trials with experience of PPI in the area or who expresses their views on PPI. The electronic bibliographic databases CINAHL, MEDLINE, PsycINFO, EMBASE, Web of Science and the Maternity and Infant Care (OVID) will be searched from inception. Qualitative studies, mixed-methods studies where the qualitative data can be extracted independently, and surveys with open-ended qualitative questions, will be included. Aims: The QES seeks to explore stakeholders’, including PPI contributors, trial participants and guardians, and trial researchers, perspectives and experiences of PPI in maternal and neonatal clinical trials. Discussion: THE QES will provide an understanding of how PPI is understood, operationalised and experienced by stakeholders in maternal and neonatal clinical trials, with the aim of identifying good practice and areas for improvement. PROSPERO registration: CRD42023383878 (2nd March 2023)
Keywords	patient and public involvement ; trial methodology ; neonatal care ; maternal care ; clinical trials ; GRIPP2 ; eng ; Medicine ; R
Subject code	610
Language	English
Publishing date	2023-09-01T00:00:00Z
Publisher	F1000 Research Ltd
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Methodology in core outcome set (COS) development

Alexandria Remus / Valerie Smith / Francesca Wuytack

BMC Medical Research Methodology, Vol 21, Iss 1, Pp 1-

the impact of patient interviews and using a 5-point versus a 9-point Delphi rating scale on core outcome selection in a COS development study

2021 Volume 15

Abstract: Abstract Background As the development of core outcome sets (COS) increases, guidance for developing and reporting high-quality COS continues to evolve; however, a number of methodological uncertainties still remain. The objectives of this study were: (1) ...

Abstract	Abstract Background As the development of core outcome sets (COS) increases, guidance for developing and reporting high-quality COS continues to evolve; however, a number of methodological uncertainties still remain. The objectives of this study were: (1) to explore the impact of including patient interviews in developing a COS, (2) to examine the impact of using a 5-point versus a 9-point rating scale during Delphi consensus methods on outcome selection and (3) to inform and contribute to COS development methodology by advancing the evidence base on COS development techniques. Methods Semi-structured patient interviews and a nested randomised controlled parallel group trial as part of the Pelvic Girdle Pain Core Outcome Set project (PGP-COS). Patient interviews, as an adjunct to a systematic review of outcomes reported in previous studies, were undertaken to identify preliminary outcomes for including in a Delphi consensus survey. In the Delphi survey, participants were randomised (1:1) to a 5-point or 9-point rating scale for rating the importance of the list of preliminary outcomes. Results Four of the eight patient interview derived outcomes were included in the preliminary COS, however, none of these outcomes were included in the final PGP-COS. The 5-point rating scale resulted in twice as many outcomes reaching consensus after the 3-round Delphi survey compared to the 9-point scale. Consensus on all five outcomes included in the final PGP-COS was achieved by participants allocated the 5-point rating scale, whereas consensus on four of these was achieved by those using the 9-point scale. Conclusions Using patient interviews to identify preliminary outcomes as an adjunct to conducting a systematic review of outcomes measured in the literature did not appear to influence outcome selection in developing the COS in this study. The use of different rating scales in a Delphi survey, however, did appear to impact on outcome selection. The 5-point scale demonstrated greater congruency than the 9-point scale with the outcomes included in the final PGP-COS. Future research to substantiate our findings and to explore the impact of other rating scales on outcome selection during COS development, however, is warranted.
Keywords	Core outcome set ; Rating scales ; Delphi methods ; Consensus methods ; Pelvic girdle pain ; Patient interviews ; Medicine (General) ; R5-920
Subject code	306 ; 300
Language	English
Publishing date	2021-01-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Early warning systems in maternity care

Deirdre O'Malley / Valerie Smith / Kumaresan Cithambaram

HRB Open Research, Vol

protocol for a qualitative evidence synthesis of maternity care providers’ views and experiences [version 1; peer review: 2 approved]

2021 Volume 4

Abstract: Background: Early warning systems (EWS) have been widely adopted for use in maternity settings internationally. The idea in using these systems is early recognition of potential or actual clinical deterioration in pregnant or postpartum women, and ... ...

Abstract	Background: Early warning systems (EWS) have been widely adopted for use in maternity settings internationally. The idea in using these systems is early recognition of potential or actual clinical deterioration in pregnant or postpartum women, and escalation of care. Barriers to successful implementation and use of EWS, however, have been identified. If EWS are to be applied consistently, a greater understanding of the views and experiences of EWS from the perspectives of those using and applying EWS in maternity practice is needed. This protocol describes a qualitative evidence synthesis of maternity care providers’ (midwives, obstetricians, and allied maternity care professionals) views and experiences of EWS use and application in practice. Methods: Studies will be included in the review if they report on maternity care providers use and application of EWS in any birth setting. Qualitative studies and studies of mixed methods design, where qualitative data can be extracted separately, will be included. To source relevant literature the electronic databases of MEDLINE, CINHAL, Web of Science Core Collection (incorporating Social Science Citation Index) and Maternity and Infant Care (MIDIRS), from date of inception, will be searched. The methodological quality of the included studies will be appraised using the 12-criteria of the assessment tool developed by the Evidence for Policy and Practice Information and Co-ordinating Centre. Thematic synthesis will be used for synthesising the qualitative data from included studies. The confidence in the findings will be assessed using the Grading of Recommendations Assessment, Development and Evaluation-Confidence in the Evidence from Reviews of Qualitative research. Conclusions: The findings of this qualitative evidence synthesis may provide valuable information on the barriers, challenges, and facilitators for EWS use based on the experiences of those directly involved in EWS application in maternity care provision. PROSPERO registration: CRD42021235137 (08/04/2021)
Keywords	Early warning systems ; maternity early warning score ; MEWS ; clinical deterioration ; systematic review ; qualitative evidence synthesis. ; eng ; Medicine ; R
Subject code	360
Language	English
Publishing date	2021-05-01T00:00:00Z
Publisher	F1000 Research Ltd
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: A concept analysis of ‘trial recruitment’ using the hybrid model [version 2; peer review

Shaun Treweek / Declan Devane / Hannah Delaney / Andrew Hunter / Carrol Gamble / Nicola Mills / Valerie Smith

HRB Open Research, Vol

2 approved]

2022 Volume 3

Abstract: Background: The International Committee of Medical Journal Editors (ICMJE) requires trials submitted for publication to be registered before recruitment of the first participant; however, there is ambiguity around the definition of recruitment and in ... ...

Abstract	Background: The International Committee of Medical Journal Editors (ICMJE) requires trials submitted for publication to be registered before recruitment of the first participant; however, there is ambiguity around the definition of recruitment and in anchoring the trial start date, end date, and recruitment, or as often interchangeably referred to, enrolment, temporally to trial processes. There is potential for variation in how recruitment is reported and understood in trial protocols and trial reports. We report on a concept analysis of ‘trial recruitment’ and develop an operational definition of ‘trial recruitment’. Methods: A concept analysis using the hybrid model. In Phase 1 we examined randomised and non-randomised trial reports (n=150) published between January 2018 and June 2019 to conceptually explore how recruitment was temporally aligned to the four time-points of screening/eligibility, consent, randomisation and allocation. A preliminary operational definition of ‘trial recruitment’ was determined. This definition was further explored, refined and finalised in Phase 2 (field work), through an interactive, discussion-focused workshop with trial recruiters and trial participants. Results: Of the 150 trial reports analysed, over half did not identify a clear time point of when recruitment took place and varying terminology is used when reporting on trial recruitment. In Phase 2, the workshop attendees agreed that the proposed definition of ‘trial recruitment’ offers an acceptable definition that provides a standardised approach of how trial recruitment may be temporally understood as part of overall trial processes. Conclusion: There is ambiguity around temporal descriptions of ‘trial recruitment’ in health care journals. Informed by the findings of this concept analysis we propose a temporal operational definition of trial recruitment based on i) trial recruitment of an individual or cluster and ii) the trial recruitment period.
Keywords	Concept analysis ; Trial recruitment ; Trial report ; Trial enrolment ; eng ; Medicine ; R
Subject code	410
Language	English
Publishing date	2022-04-01T00:00:00Z
Publisher	F1000 Research Ltd
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: What would reduce caesarean section rates?-Views from pregnant women and clinicians in Ireland.

Louise Gallagher / Valerie Smith / Margaret Carroll / Kathleen Hannon / Denise Lawler / Cecily Begley

PLoS ONE, Vol 17, Iss 4, p e

2022 Volume 0267465

Abstract: Background Caesarean section rates continue to rise in most parts of the world. While CS is a lifesaving procedure there is evidence that, beyond a certain threshold, CS rates may contribute to increased maternal and perinatal morbidity. This study aimed ...

Abstract	Background Caesarean section rates continue to rise in most parts of the world. While CS is a lifesaving procedure there is evidence that, beyond a certain threshold, CS rates may contribute to increased maternal and perinatal morbidity. This study aimed to elicit the views of pregnant women's and clinicians' on how CS rates might be reduced. Methods Pregnant women and their partners, and clinicians working with pregnant women in a maternity hospital in the Republic of Ireland of Ireland, were invited to participate in focus groups. Eligibility criteria included all women attending antenatal classes and clinicians working with pregnant women. A convenience sample was used and interviews were audio recorded, transcribed, and analysed using thematic analysis. Results Four focus group interviews were conducted with 30 clinicians and 15 pregnant women and two partners participated in three focus groups. A further two women were interviewed individually. Participants expressed a view that rising CS rates were impacted by a societal perception that CS had become a 'normal mode of birth'. Suggestions for reducing CS rates were offered by clinicians and pregnant women and their partners. Conclusions Clinicians and pregnant women consider that CS rates can be reduced if a shared philosophy supporting normal birth is prioritised alongside adequate resourcing. Women and their partners also believe that enhanced communication with clinicians is central to reducing CS rates.
Keywords	Medicine ; R ; Science ; Q
Subject code	360
Language	English
Publishing date	2022-01-01T00:00:00Z
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: Antenatal and intrapartum interventions for reducing caesarean section, promoting vaginal birth, and reducing fear of childbirth

Valerie Smith / Louise Gallagher / Margaret Carroll / Kathleen Hannon / Cecily Begley

PLoS ONE, Vol 14, Iss 10, p e

An overview of systematic reviews.

2019 Volume 0224313

Abstract: Concern has been expressed globally over rising caesarean birth rates. Recently, the International Federation of Gynaecology and Obstetrics (FIGO) called for help from governmental bodies, professional organisations, women's groups, and other ... ...

Abstract	Concern has been expressed globally over rising caesarean birth rates. Recently, the International Federation of Gynaecology and Obstetrics (FIGO) called for help from governmental bodies, professional organisations, women's groups, and other stakeholders to reduce unnecessary caesareans. As part of a wider research initiative, we conducted an overview of systematic reviews of antenatal and intrapartum interventions, and reports of evidence based recommendations, to identify and highlight those that have been shown to be effective for reducing caesarean birth, promoting vaginal birth and reducing fear of childbirth. Following registration of the review protocol, (PROSPERO 2018 CRD42018090681), we searched The Cochrane Database of Systematic Reviews, PubMed, CINAHL and EMBASE (Jan 2000-Jan 2018) and searched for grey literature in PROSPERO, and on websites of health professional and other relevant bodies. Screening and selection of reviews, quality appraisal using AMSTAR-2, and data extraction were performed independently by pairs of at least two reviewers. Excluding reviews assessed as 'critically low' on AMSTAR-2 (n = 54), 101 systematic reviews, and 10 reports of evidence based recommendations were included in the overview. Narrative synthesis was performed, due to heterogeneity of review methodology and topics. The results highlight twenty-five interventions, across 17 reviews, that reduced the risk of caesarean, nine interventions across eight reviews that increased the risk of caesarean, eight interventions that reduced instrumental vaginal birth, four interventions that increased spontaneous vaginal birth, and two interventions that reduced fear of childbirth. This overview of reviews identifies and highlights interventions that have been shown to be effective for reducing caesarean birth, promoting vaginal births and reducing fear of childbirth. In recognising that clinical practices change over time, this overview includes reviews published from 2000 onwards only, thus providing contemporary evidence, ...
Keywords	Medicine ; R ; Science ; Q
Subject code	610
Language	English
Publishing date	2019-01-01T00:00:00Z
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: Is Exercise the Best Medicine during a COVID-19 Pandemic? Comment on Constandt, B.; Thibaut, E.; De Bosscher, V.; Scheerder, J.; Ricour, M.; Willem, A. Exercising in Times of Lockdown

Tamara Hew-Butler / Valerie Smith-Hale / Matthew Van Sumeren / Jordan Sabourin / Phillip Levy

International Journal of Environmental Research and Public Health, Vol 17, Iss 5730, p

An Analysis of the Impact of COVID-19 on Levels and Patterns of Exercise among Adults in Belgium. Int. J. Environ. Res. Public Health 2020, 17 , 4144

2020 Volume 5730

Abstract: From Constandt et al.’s survey of 13,515 Belgium respondents, regular physical activity can be successfully initiated and sustained during a lockdown, with appropriate social distancing measures. Documentation that 77% of highly active people and 58% of ... ...

Abstract	From Constandt et al.’s survey of 13,515 Belgium respondents, regular physical activity can be successfully initiated and sustained during a lockdown, with appropriate social distancing measures. Documentation that 77% of highly active people and 58% of low active people exercised as much or more following the institution of a nationwide lockdown was impressive, given that the cases of COVID-19 were accelerating at that time. The Belgian government’s central promotion of exercise, to boost both the mental and physical health of the population, likely contributed to the health, tolerance, and ultimate success of lockdown. In this commentary, we wish to pose a follow-up query which highlights the potential detrimental effects of intense exercise (competition) performed without social distancing measures. The proposed graphical abstract elucidates these possible risks, in contrast to the favorable results outlined in Constandt et al.’s study.
Keywords	COVID-19 ; exercise ; pandemic ; Medicine ; R ; covid19
Subject code	796
Language	English
Publishing date	2020-08-01T00:00:00Z
Publisher	MDPI AG
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Development of a core outcome set (COS) for studies relating to awareness and clinical management of reduced fetal movement

Dexter J. L. Hayes / Declan Devane / Jo C. Dumville / Valerie Smith / Tanya Walsh / Alexander E. P. Heazell

Trials, Vol 22, Iss 1, Pp 1-

study protocol

2021 Volume 6

Abstract: Abstract Background Concerns regarding reduced fetal movements (RFM) are reported in 5–15% of pregnancies, and RFM are associated with adverse pregnancy outcomes including fetal growth restriction and stillbirth. Studies have aimed to improve pregnancy ... ...

Abstract	Abstract Background Concerns regarding reduced fetal movements (RFM) are reported in 5–15% of pregnancies, and RFM are associated with adverse pregnancy outcomes including fetal growth restriction and stillbirth. Studies have aimed to improve pregnancy outcomes by evaluating interventions to raise awareness of RFM in pregnancy, such as kick counting, evaluating interventions for the clinical management of RFM, or both. However, there is not currently a core outcome set (COS) for studies of RFM. This study aims to create a COS for use in research studies that aim to raise awareness of RFM and/or evaluate interventions for the clinical management of RFM. Methods A systematic review will be conducted, to identify outcomes used in randomised and non-randomised studies with control groups that aimed to raise awareness of RFM (for example by using mindfulness techniques, fetal movement counting, or other tools such as leaflets or mobile phone applications) and/or that evaluated the clinical management of RFM. An international Delphi consensus will then be used whereby stakeholders will rate the importance of the outcomes identified in the systematic review in (i) awareness and (ii) clinical management studies. The preliminary lists of outcomes will be discussed at a consensus meeting where one final COS for awareness and management, or two discrete COS (one for awareness and one for management), will be agreed upon. Discussion A well-developed COS will provide researchers with the minimum set of outcomes that should be measured and reported in studies that aim to quantify the effects of interventions.
Keywords	Core outcome set ; Pregnancy ; Reduced fetal movement ; Medicine (General) ; R5-920
Subject code	610
Language	English
Publishing date	2021-12-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Developing a core outcome set (COS) for Dementia with Lewy bodies (DLB) [version 2; peer review

Ian J Saldanha / Elke Kalbe / Dag Aarsland / Emilia Grycuk / Iracema Leroi / Ann-Kristin Folkerts / Emily Eichenholtz / Irina Kinchin / Valerie Smith / Rachel Fitzpatrick / Joseph PM Kane / John-Paul Taylor / Sara Betzhold / Rachel Thompson / Gillian Daly

HRB Open Research, Vol

1 approved, 2 approved with reservations]

2023 Volume 5

Abstract: Background: Dementia with Lewy bodies (DLB) is an important cause of dementia with a range of clinical manifestations, including motor, neuropsychiatric, and autonomic symptoms. Compared with more common forms of dementia such as Alzheimer’s disease, DLB ...

Abstract	Background: Dementia with Lewy bodies (DLB) is an important cause of dementia with a range of clinical manifestations, including motor, neuropsychiatric, and autonomic symptoms. Compared with more common forms of dementia such as Alzheimer’s disease, DLB has been the focus of significantly fewer treatment studies, often with diverse outcome measures, making comparison and clinical implementation difficult. A core outcome set (COS) can address this by ensuring that data are comparable, relevant, useful, and usable for making the best healthcare decisions. Methods: Using a multi-stage approach, development of the DLB-COS will include the following stages: (1) A systematic review, following PRISMA guidelines to create an initial long list of outcomes; (2) A two-round online Delphi including clinicians, scientists, policymakers, and individuals with lived experience of DLB and their representatives; (3) An online consensus meeting to agree on the final core list of outcomes (the final DLB-COS) for use in research and clinical practice; (4) A literature search to identify appropriate measurement instruments for the DLB-COS outcomes; (5) A final consensus meeting of the professional stakeholders who attended the online consensus meeting to agree on the instruments that should be used to measure the outcomes in the DLB-COS; and (6) Global dissemination. Discussion: This is a multi-stage project to develop a COS to be used in treatment trials for DLB. A DLB-COS will ensure the selection of relevant outcomes and will identify the instruments to be used to measure DLB globally.
Keywords	Dementia ; Dementia with Lewy Bodies ; Core Outcome Set ; Delphi ; Systematic Review ; Ageing ; eng ; Medicine ; R
Subject code	360
Language	English
Publishing date	2023-10-01T00:00:00Z
Publisher	F1000 Research Ltd
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: The effectiveness of digital multimedia presentation of trial information on recruitment and retention of patients

Sinead Duane / Akke Vellinga / Valerie Smith / Marie Tierney / Claire Beecher / Megan Burke / Andrew W. Murphy / Declan Devane

HRB Open Research, Vol

Protocol for a study within a trial (SWAT). [version 1; peer review: 2 approved]

2020 Volume 3

Abstract: Background: Studies within trials (SWATs) present an opportunity to examine design factors that may impact on the successful delivery of trials. One area in need of research is trial recruitment. Recruiting patients to trials is a major challenge facing ... ...

Abstract	Background: Studies within trials (SWATs) present an opportunity to examine design factors that may impact on the successful delivery of trials. One area in need of research is trial recruitment. Recruiting patients to trials is a major challenge facing trialists. Failure to meet recruitment targets can result in delays and underpowered studies. This SWAT evaluates the effectiveness of hand-held digital multimedia presentation of trial information and standard written patient information to potential participants on recruitment and retention to a host trial. Methods: This is the protocol for SWAT 15, a two-group, embedded parallel randomised controlled trial (RCT) (ISRCTN12838042) designed within a host trial - the SATIN trial (ISRCTN88111427), a RCT designed for implementation in the Irish primary care setting. The SWAT eligibility criteria was determined by the host trial. General practices who agree to participate in the host trial will provide women (participants) who are willing to consider participating in the host trial with either a multimedia digital information resource facilitated through a handheld tablet device, plus a written participant information leaflet (Intervention) or a written participant information leaflet (comparator). Outcomes are recruitment and retention to the host SATIN trial and participant’s quality of decision-making. Discussion: Although designed to be implemented in a host trial, the host trial, was suspended and therefore this SWAT was not implemented. The protocol and the lessons learnt whilst developing it offer guidance to researchers who wish to answer similar research questions in the future in a similar context or setting. Trial registration: ISRCTN Registry ISRCTN12838042 (11/10/2017)
Keywords	Medicine ; R
Subject code	302
Language	English
Publishing date	2020-03-01T00:00:00Z
Publisher	F1000 Research Ltd
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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