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Article ; Online: Online randomised trials with children

Simone Lepage / Aislinn Conway / Noah Goodson / Paul Wicks / Laura Flight / Declan Devane

PLoS ONE, Vol 18, Iss 5, p e

A scoping review.

2023 Volume 0280965

Abstract: 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 ... ...

Abstract	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 used to create and conduct entirely online-decentralised trials with children and (b) determine the gaps in the knowledge in this field. This review will describe the methods used in these trials to identify their facilitators and the gaps in the knowledge. Methods The methods were informed by guidance from the Joanna Briggs Institute and the PRISMA extension for scoping reviews. We systematically searched MEDLINE, CENTRAL, CINAHL, and Embase databases, trial registries, pre-print servers, and the internet. We included randomised and quasi-randomised trials conducted entirely online with participants under 18 published in English. A risk of bias assessment was completed for all included studies. Results Twenty-one trials met our inclusion criteria. The average age of participants was 14.6 years. Social media was the most common method of online recruitment. Most trials employed an external host website to store and protect their data. Duration of trials ranged from single-session interventions up to ten weeks. Fourteen trials compensated participants. Eight trials involved children in their trial design process; none reported compensation for this. Most trials had a low risk of bias in "random sequence generation", "selective reporting", and "other". Most trials had a high risk of bias in "blinding participants and personnel", "blinding of outcome assessment", and "incomplete outcome data". "Allocation concealment" was unclear in most studies. Conclusions There was a lack of transparent reporting of the recruitment, randomisation, and retention methods used in many of the trials included in this review. Patient and public involvement (PPI) was not common, and the ...
Keywords	Medicine ; R ; Science ; Q
Subject code	610
Language	English
Publishing date	2023-01-01T00:00:00Z
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: Online randomised trials with children

Simone Lepage / Aislinn Conway / Noah Goodson / Paul Wicks / Laura Flight / Declan Devane

PLoS ONE, Vol 18, Iss

A scoping review

2023 Volume 5

Abstract	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 used to create and conduct entirely online-decentralised trials with children and (b) determine the gaps in the knowledge in this field. This review will describe the methods used in these trials to identify their facilitators and the gaps in the knowledge. Methods The methods were informed by guidance from the Joanna Briggs Institute and the PRISMA extension for scoping reviews. We systematically searched MEDLINE, CENTRAL, CINAHL, and Embase databases, trial registries, pre-print servers, and the internet. We included randomised and quasi-randomised trials conducted entirely online with participants under 18 published in English. A risk of bias assessment was completed for all included studies. Results Twenty-one trials met our inclusion criteria. The average age of participants was 14.6 years. Social media was the most common method of online recruitment. Most trials employed an external host website to store and protect their data. Duration of trials ranged from single-session interventions up to ten weeks. Fourteen trials compensated participants. Eight trials involved children in their trial design process; none reported compensation for this. Most trials had a low risk of bias in “random sequence generation”, “selective reporting”, and “other”. Most trials had a high risk of bias in “blinding participants and personnel”, “blinding of outcome assessment”, and “incomplete outcome data”. “Allocation concealment” was unclear in most studies. Conclusions There was a lack of transparent reporting of the recruitment, randomisation, and retention methods used in many of the trials included in this review. Patient and public involvement (PPI) was not common, and the ...
Keywords	Medicine ; R ; Science ; Q
Subject code	610
Language	English
Publishing date	2023-01-01T00:00:00Z
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: Online randomised trials with children

Noah Goodson / Aislinn Conway / Paul Wicks / Simone Lepage / Declan Devane

HRB Open Research, Vol

A scoping review protocol [version 1; peer review: 2 approved]

2022 Volume 5

Abstract: 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) ...

Abstract	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 employing online methods have gained traction. Decentralised methods lend themselves to certain types of trials and can offer advantages over traditional trial methods, potentially increasing participant reach and diversity and decreasing research waste. However, decentralised trials that have all aspects of the trial exclusively online are not yet common, and those involving children even less so. This scoping review will describe and evaluate the methods used in these trials to understand how they may be effectively employed. Methods: Methods are informed by guidance from the Joanna Briggs Institute and the Preferred Reporting Items for Systematic Reviews and Meta-analyses extension for scoping reviews. The search strategy was developed in consultation with an information specialist for the following databases: MEDLINE, CENTRAL, CINAHL, and Embase. Grey literature searches will be completed with the consultation of experts in decentralised trials and digital health using internet searches and suitable trial registries. Once identified, included full-text studies’ references will be manually searched for any trials that may have been missed. We will include randomised and quasi-randomised trials conducted exclusively online with participants under the age of 18 published in English. We will not limit by country of conduct or date of publication. Data will be collected using a data charting tool and presented in text, graphical, and tabular formats. Ethics and Dissemination: Ethical approval is not needed since all data sources used are publicly available. The review will be available as a preprint before publication in an open-access, peer-reviewed journal.
Keywords	Internet-based ; Randomised trials ; Decentralised ; Digital ; E-health ; Web-based ; eng ; Medicine ; R
Subject code	028
Language	English
Publishing date	2022-06-01T00:00:00Z
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: Factors influencing the statistical planning, design, conduct, analysis and reporting of trials in health care

Marina Zaki / Lydia O'Sullivan / Declan Devane / Ricardo Segurado / Eilish McAuliffe

Contemporary Clinical Trials Communications, Vol 26, Iss , Pp 100897- (2022)

A systematic review

2022

Abstract: Background: Trials in health care are prospective human research studies designed to test the effectiveness and safety of health care interventions, such as medications, surgeries, medical devices and other treatment or prevention interventions. ... ...

Abstract	Background: Trials in health care are prospective human research studies designed to test the effectiveness and safety of health care interventions, such as medications, surgeries, medical devices and other treatment or prevention interventions. Statistics is an important and powerful tool in trials. Inappropriately designed trials and/or inappropriate statistical analysis produce unreliable results and a lack of transparency when reported, with limited clinical use. Aim: This systematic literature review aimed to identify, describe and synthesise factors contributing to or influencing the statistical planning, design, conduct, analysis and reporting of trials. Methods: Information sources were retrieved from the following electronic citation databases: PubMed, Web of Science, PsycINFO, and CINAHL and the grey literature repository: OpenGrey. 90 articles and guidelines were included in this review. A narrative, thematic synthesis identified the key factors influencing the statistical planning, design, conduct, analysis and reporting of trials in health care. Findings and conclusion: We identified three analytical themes within which factors are grouped. These are: “what makes a statistician?“, “the need for dynamic statistical involvement and collaboration throughout a trial – it's not just about the numbers”, “and the “accountability of statisticians in ensuring the safety of trial participants and the integrity of trial data”. While important insights emerged about the qualifications, training, roles, and responsibilities of statisticians and their collaboration with other team members in a trial, further empirical research is warranted to elicit the perceptions of trial team members at the centre of statistics in trials.
Keywords	Systematic review ; Trials ; Statistics ; Medicine (General) ; R5-920
Subject code	306
Language	English
Publishing date	2022-04-01T00:00:00Z
Publisher	Elsevier
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Implementing an initiative promote evidence-informed practice

Aislinn Conway / Maura Dowling / Declan Devane

BMC Medical Education, Vol 19, Iss 1, Pp 1-

part 2—healthcare professionals’ perspectives of the evidence rounds programme

2019 Volume 17

Abstract: Abstract Background The translation of research into clinical practice is a key component of evidence-informed decision making. We implemented a multi-component dissemination and implementation strategy for healthcare professionals (HCPs) called Evidence ...

Abstract	Abstract Background The translation of research into clinical practice is a key component of evidence-informed decision making. We implemented a multi-component dissemination and implementation strategy for healthcare professionals (HCPs) called Evidence Rounds. We report the findings of focus groups and interviews with HCPs to explore their perceptions of Evidence Rounds and help inform the implementation of future similar initiatives. This is the second paper in a two-part series. Methods We employed total population, purposive sampling by targeting all of the health care professionals who attended or presented at group sessions exploring the evidence on clinical questions or topics chosen and presented by the HCPs. We conducted and audio-recorded in-person focus groups and one-to-one interviews, which were then transcribed verbatim. Two authors independently coded transcripts. NVivo software was used to collate the primary data and codes. We analysed data guided by the five steps involved in framework analysis; 1) familiarization 2) identifying a thematic framework 3) indexing 4) charting 5) mapping and interpretation. Results Thirteen HCPs participated, of which 6 were medical doctors an d 7 were nursing or midwifery staff. We identified the following key domains; organisational readiness for change, barriers and facilitators to attendance, barriers and facilitators to presenting, communication and dissemination of information, and sustainability. During focus groups and interviews HCPs reported that Evidence Rounds had a positive impact on their continuing education and clinical practice. They also provided insights into how future initiatives could be optimised to support and enable them to narrow the gap between research evidence and practice. Conclusions Individual, departmental and organisational level contextual factors can play a major role in implementation within complex health services. HCPs highlighted how in combination with clinical guideline development, implementation of evidence could be ...
Keywords	Dissemination ; Implementation science ; Knowledge translation ; Evidence-informed practice ; Health services research ; Barriers ; Special aspects of education ; LC8-6691 ; Medicine ; R
Subject code	360
Language	English
Publishing date	2019-03-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Prevention of striae gravidarum

Miriam Brennan / Mike Clarke / John Newell / Declan Devane

Trials, Vol 19, Iss 1, Pp 1-

study protocol for a pilot randomised controlled trial

2018 Volume 9

Abstract: Abstract Background Striae gravidarum (stretch marks) are considered the most common connective tissue/skin change in pregnancy. Though not a health issue they can affect women in different ways, for example, cause stress or be an aesthetic or cosmetic ... ...

Abstract	Abstract Background Striae gravidarum (stretch marks) are considered the most common connective tissue/skin change in pregnancy. Though not a health issue they can affect women in different ways, for example, cause stress or be an aesthetic or cosmetic concern. Many women use one or more of the commercially available products to try and prevent their development during pregnancy despite the fact that that there is a lack of high-quality evidence to support their use. There is a dearth of studies on the prevention of striae gravidarum and large, robust trials are lacking. Until such time as more products are investigated, much of the knowledge remains anecdotal. This pilot study will evaluate the feasibility of conducting a study to evaluate the effectiveness of a commercially available moisturising oil compared to no treatment for the prevention and reduction in severity of striae gravidarum. Methods The definitive study will be a randomised controlled trial to evaluate the effectiveness of a moisturising oil (commercially available moisturising oil) compared to no treatment for the prevention and reduction in severity of striae gravidarum. This protocol is for a pilot randomised trial to evaluate the feasibility of conducting such a study. The pilot study will be a two-arm, unblinded, pragmatic parallel randomised trial with a 1:1 randomisation ratio between control and intervention groups. Women in the intervention group will be asked to apply a moisturising oil to their abdomen during pregnancy, while women in the control group will not use any treatment. It is proposed to recruit 20 primigravida, who are 12–16 weeks pregnant from an Irish Maternity Hospital, in each arm to assess the feasibility of running such a trial. Discussion This pilot trial will evaluate the feasibility of conducting the main study to evaluate the effectiveness of a moisturising oil (commercially available moisturising oil) compared to no treatment for the prevention and reduction in severity of striae gravidarum. It will potentially initiate the generation of high-quality evidence to guide women in their choice of anti-stretch mark product. Trial registration ISRCTN Registry, ISRCTN76992326. Registered on 14 July 2017.
Keywords	Striae gravidarum ; Stretch marks ; Protocol ; Pilot trial ; Randomised controlled trial ; Medicine (General) ; R5-920
Subject code	360 ; 150
Language	English
Publishing date	2018-10-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Developing guideline-based key performance indicators for recurrent miscarriage care

Marita Hennessy / Laura Linehan / Rebecca Dennehy / Declan Devane / Rachel Rice / Sarah Meaney / Keelin O’Donoghue

Research Involvement and Engagement, Vol 8, Iss 1, Pp 1-

lessons from a multi-stage consensus process with a diverse stakeholder group

2022 Volume 18

Abstract: 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 ...

Abstract	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. In this paper, we describe how we worked with women and men with lived experience, doctors, nurses, managers, and others, to develop and agree on a list KPIs for recurrent miscarriage care in Ireland. We will use these to check what services are doing across the country and what could be done better. Participants filled out surveys and took part in meetings to vote on and agree on what KPIs were important to include. They also shared their views and experiences of taking part in this work. Together, we developed 110 KPIs for recurrent miscarriage care. These include measures of how care is structured, counselling and supports, investigations and treatments provided, and health-related outcomes. Participants’ valued the different views that people brought to discussions and what they learned. They suggested ways that the process could be made more participant-friendly. For example, being up-front about the time it would take, explaining medical terms more, and cutting down on the number of items to be rated in surveys. It is important and possible to develop KPIs with different groups, particularly those with lived experience. Learning from our study may help others who want to do similar projects, such as develop KPIs or guidelines for care.
Keywords	Early pregnancy loss ; Care quality ; Quality indicators ; Quality improvement ; Delphi technique ; Patient and public involvement ; Medicine ; R ; Medicine (General) ; R5-920
Subject code	360
Language	English
Publishing date	2022-05-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Publisher Correction to

Marita Hennessy / Laura Linehan / Rebecca Dennehy / Declan Devane / Rachel Rice / Sarah Meaney / Keelin O’Donoghue

Research Involvement and Engagement, Vol 8, Iss 1, Pp 1-

Developing guideline-based key performance indicators for recurrent miscarriage care: lessons from a multi-stage consensus process with a diverse stakeholder group

2022 Volume 2

Keywords	Medicine ; R ; Medicine (General) ; R5-920
Language	English
Publishing date	2022-08-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: A protocol for a systematic review of clinical practice guidelines for recurrent miscarriage [version 3; peer review

Marita Hennessy / Rebecca Dennehy / Sarah Meaney / Declan Devane / Keelin O'Donoghue

HRB Open Research, Vol

2 approved, 2 approved with reservations]

2020 Volume 3

Abstract: Recurrent miscarriage (RM) was recently re-defined by the European Society of Human Reproduction and Embryology (ESHRE) as the loss of two or more consecutive pregnancies. Before this, and indeed still in some countries, RM was defined as three or more ... ...

Abstract	Recurrent miscarriage (RM) was recently re-defined by the European Society of Human Reproduction and Embryology (ESHRE) as the loss of two or more consecutive pregnancies. Before this, and indeed still in some countries, RM was defined as three or more consecutive pregnancy losses. While the incidence of RM depends on the definition employed and population studied, it is generally accepted to affect 1-6% of women of reproductive age. Clinical practice guidelines (CPGs) for RM have been published by some professional organisations. While there are CPGs on miscarriage in Ireland, there are none concerning RM specifically. The aim of this systematic review is to identify, appraise and describe published CPGs for the management, investigation and/or follow-up of RM within high-income countries. Electronic databases (MEDLINE (Ovid®; 1946), Embase® (Elsevier; 1980), CINAHL Complete (EBSCOhost; 1994), Web of Science™ (Thomson Reuters), Scopus (Elsevier; 2004), and Open Grey (INIST-CNRS; 2011)), selected guideline repositories, and the websites of professional societies will be searched to identify CPGs, published within the last 20 years, for potential inclusion. Two reviewers will review abstracts and full texts independently against the eligibility criteria. Characteristics and recommendations of included CPGs will be extracted by one reviewer and double-checked by another. Two reviewers will use the Appraisal of Guidelines for Research and Evaluation version 2 (AGREE II) instrument independently to assess the quality of the included CPGs. Narrative synthesis will be conducted to appraise and compare CPGs and their recommendations or guidance therein. The identification, appraisal and description of published CPGs in other high-income countries will be a valuable first step in informing efforts to promote the optimisation and standardisation of RM care.
Keywords	Medicine ; R
Subject code	070
Language	English
Publishing date	2020-10-01T00:00:00Z
Publisher	F1000 Research Ltd
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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