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  1. Article ; Online: An Overview of Post-Publication Peer Review

    Lydia O’Sullivan / Lai Ma / Peter Doran

    Scholarly Assessment Reports, Vol 3, Iss

    2021  Volume 1

    Abstract: The increasing demand for swift dissemination of research findings, combined with the drive towards transparency and open science has challenged the established approach to peer review in the journal publication system. Post-publication peer review (PPPR) ...

    Abstract The increasing demand for swift dissemination of research findings, combined with the drive towards transparency and open science has challenged the established approach to peer review in the journal publication system. Post-publication peer review (PPPR) takes place when an article is published 'before' peer reviewers are sought, and takes a number of forms, including Letters to the Editor, blogs, social media and online platforms such as 'F1000 Research'. Aside from the speed at which information can be shared with the research community, PPPR also has the potential advantage of facilitating a dynamic discussion between researchers and gaining insights from a wider range of contributors. While pre-publication peer review is still regarded as the ‘gold standard’, the merits of PPPR are increasingly being recognised. PPPR has the potential to enable dissemination, promote meaningful discussions and collaboration between researchers and be an efficient engine of open science. However, there remains some significant concerns that expedited publication without prior peer review may result in the dissemination of poor-quality data and findings from badly designed studies. Whilst this risk is also present in traditional prepublication peer review, it is heightened in its absence. This is particularly true where media can disseminate findings which have not yet been interrogated closely and distinction is not easily drawn between peer reviewed and non-peer reviewed findings. There is also the need for an integrated and accessible system so that both authors and readers can easily benefit from PPPR. This narrative literature review explores some of the platforms which facilitate PPPR in the field of academic publishing, including journals which carry out all of their peer review post-publication, Letters to the Editor/Commentaries and academic social networks. Policy highlights The changing landscape of scholarly publishing, including open science and preprint publications demands changes in peer review mechanisms including open peer review and post-publication peer review. Post-publication peer review enhances and encourages timely dissemination of research findings but can also be vulnerable to trolling and distribution of incomplete and inconclusive research findings. Post-publication peer review encourages good faith collaboration, especially for tackling crises such as the COVID-19 pandemic, when every minute counts and when solving problems for common/public good are of utmost importance. Research evaluation policy should consider the contributions of post-publication peer review by, for example, establishing a verified reviewer system to acknowledge the contributions, which can overcome some unresolved problems and issues of open peer review.
    Keywords open science ; open review ; peer review ; post-publication peer review ; Bibliography. Library science. Information resources ; Z
    Subject code 306
    Language English
    Publishing date 2021-11-01T00:00:00Z
    Publisher Levy Library Press
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  2. 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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  3. Article ; Online: Contributory factors to the evolution of the concept and practice of informed consent in clinical research

    Lydia O'Sullivan / Rachel Crowley / Éilish McAuliffe / Peter Doran

    Contemporary Clinical Trials Communications, Vol 19, Iss , Pp 100634- (2020)

    A narrative review

    2020  

    Abstract: Informed consent can be defined as a freely-given decision or agreement following disclosure of relevant information. This review explores how legislation surrounding informed consent has impacted upon clinical research practices, with a focus on ... ...

    Abstract Informed consent can be defined as a freely-given decision or agreement following disclosure of relevant information. This review explores how legislation surrounding informed consent has impacted upon clinical research practices, with a focus on clinical trials involving individuals with the capacity to give consent in the non-emergency setting. We also highlight the challenges which remain with the informed consent process, including those which exist in the era of data protection legislation and genetic research.Modern ethicists agree that informed consent encompasses three principal factors: disclosure of information, capacity for decision making, and voluntariness. In the context of clinical research, informed consent is now required by regulatory and ethical frameworks as well as by law, and various guidelines govern the practice of informed consent, including the Declaration of Helsinki and the Good Clinical Practice Guidelines. Historically, however, researchers acted paternalistically and included participants in research without their knowledge or consent. Following societal and political revolution, an autonomy model of consent became prevalent, and individuals became free to make individual choices about whether to participate. Despite this, it is also recognized that an individual's community has a role in supporting their decision making, and this may be a strong influence, particularly within some societies. Research scandals and controversies and whistle-blowers which exposed unethical practices in the area of informed consent also contributed to changes in societal attitudes and legislation changed as a result. Medical journals also have an established, although indirect, role in strengthening good practices surrounding informed consent.
    Keywords Informed consent ; Clinical research ; Research ethics ; Medicine (General) ; R5-920
    Subject code 170
    Language English
    Publishing date 2020-09-01T00:00:00Z
    Publisher Elsevier
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  4. Article ; Online: Readability and understandability of clinical research patient information leaflets and consent forms in Ireland and the UK

    Peter Doran / Eilish McAuliffe / Lydia O'Sullivan / Prasanth Sukumar / Rachel Crowley

    BMJ Open, Vol 10, Iss

    a retrospective quantitative analysis

    2020  Volume 9

    Abstract: Objectives The first aim of this study was to quantify the difficulty level of clinical research Patient Information Leaflets/Informed Consent Forms (PILs/ICFs) using validated and widely used readability criteria which provide a broad assessment of ... ...

    Abstract Objectives The first aim of this study was to quantify the difficulty level of clinical research Patient Information Leaflets/Informed Consent Forms (PILs/ICFs) using validated and widely used readability criteria which provide a broad assessment of written communication. The second aim was to compare these findings with best practice guidelines.Design Retrospective, quantitative analysis of clinical research PILs/ICFs provided by academic institutions, pharmaceutical companies and investigators.Setting PILs/ICFs which had received Research Ethics Committee approval in the last 5 years were collected from Ireland and the UK.Intervention Not applicable.Main outcome measures PILs/ICFs were evaluated against seven validated readability criteria (Flesch Reading Ease, Flesh Kincaid Grade Level, Simplified Measure of Gobbledegook, Gunning Fog, Fry, Raygor and New Dale Chall). The documents were also scored according to two health literacy-based criteria: the Clear Communication Index (CCI) and the Suitability Assessment of Materials tool. Finally, the documents were assessed for compliance with six best practice metrics from literacy agencies.Results A total of 176 PILs were collected, of which 154 were evaluable. None of the PILs/ICFs had the mean reading age of <12 years recommended by the American Medical Association. 7.1% of PILs/ICFs were evaluated as ‘Plain English’, 40.3%: ‘Fairly Difficult’, 51.3%: ‘Difficult’ and 1.3%: ‘Very Difficult’. No PILs/ICFs achieved a CCI >90. Only two documents complied with all six best practice literacy metrics.Conclusions When assessed against both traditional readability criteria and health literacy-based tools, the PILs/ICFs in this study are inappropriately complex. There is also evidence of poor compliance with guidelines produced by literacy agencies. These data clearly evidence the need for improved documentation to underpin the consent process.
    Keywords Medicine ; R
    Subject code 302
    Language English
    Publishing date 2020-09-01T00:00:00Z
    Publisher BMJ Publishing Group
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  5. Article ; Online: Ethical Considerations for safeguarding human participants in pandemic research

    Lydia O'Sullivan / Ronan P. Killeen / Peter Doran / Rachel K. Crowley

    HRB Open Research, Vol

    a rapid review protocol [version 2; peer review: 2 approved]

    2020  Volume 3

    Abstract: COVID-19 is a respiratory disease caused by a coronavirus, designated SARS-CoV-2, which is responsible for a global pandemic in 2020. Public interest in this disease has led to the publication of thousands of articles in the medical literature in a very ... ...

    Abstract COVID-19 is a respiratory disease caused by a coronavirus, designated SARS-CoV-2, which is responsible for a global pandemic in 2020. Public interest in this disease has led to the publication of thousands of articles in the medical literature in a very short timeframe. It is imperative that medical research into COVID-19 is conducted quickly and safely, and that due reference is given to the ethical considerations enshrined in the ICH GCP guidelines, according to the Declaration of Helsinki. In order to review the reporting of ethical considerations in these papers, we hereby propose a protocol for a systematic review of COVID-19 papers up to April 14 th 2020. The search criteria proposed for the review are based upon what would be a reasonable search conducted by a lay member of the public with access to PubMed.gov. Institutional Research Ethics Committees (RECs) face significant challenges in providing thorough and timely ethical review during the COVID-19 pandemic. It is proposed to publish the findings of this rapid review along with a summary of an institutional REC response to the challenges of reviewing and approving clinical research proposals in the time of a pandemic.
    Keywords Medicine ; R
    Subject code 170
    Language English
    Publishing date 2020-07-01T00:00:00Z
    Publisher F1000 Research Ltd
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  6. Article ; Online: A protocol for a systematic review investigating the factors influencing the statistical planning, design, conduct, analysis and reporting of clinical trials [version 1; peer review

    Marina Zaki / Marie Galligan / Lydia O'Sullivan / Declan Devane / Eilish McAuliffe

    HRB Open Research, Vol

    2 approved]

    2020  Volume 3

    Abstract: Clinical trials can be defined as prospective human research studies to test the effectiveness and safety of interventions, such as medications, surgeries, medical devices and other interventions for the management of patient care. Statistics is an ... ...

    Abstract Clinical trials can be defined as prospective human research studies to test the effectiveness and safety of interventions, such as medications, surgeries, medical devices and other interventions for the management of patient care. Statistics is an important and powerful tool in clinical trials. Inappropriately designed trials and/or inappropriate statistical analysis produce unreliable results, with limited clinical use. The aim of this systematic literature review is to identify, describe and synthesise factors contributing to or influencing the statistical planning, design, conduct, analysis and reporting of clinical trials. This protocol will describe the methodological approach taken for the following: conducting a systematic and comprehensive search for relevant articles, applying eligibility criteria for the inclusion of such articles, extracting data and information, appraising the quality of the articles, and thematically synthesizing the data to illuminate the key factors influencing statistical aspects of clinical trials.
    Keywords Medicine ; R
    Subject code 306
    Language English
    Publishing date 2020-06-01T00:00:00Z
    Publisher F1000 Research Ltd
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  7. Article ; Online: A protocol for a systematic review investigating the factors influencing the statistical planning, design, conduct, analysis and reporting of trials [version 2; peer review

    Marina Zaki / Marie Galligan / Lydia O'Sullivan / Declan Devane / Eilish McAuliffe

    HRB Open Research, Vol

    2 approved]

    2020  Volume 3

    Abstract: Trials can be defined as prospective human research studies to test the effectiveness and safety of interventions, such as medications, surgeries, medical devices and other interventions for the management of patient care. Statistics is an important and ... ...

    Abstract Trials can be defined as prospective human research studies to test the effectiveness and safety of interventions, such as medications, surgeries, medical devices and other interventions for the management of patient care. Statistics is an important and powerful tool in trials. Inappropriately designed trials and/or inappropriate statistical analysis produce unreliable results, with limited clinical use. The aim of this systematic literature review is to identify, describe and synthesise factors contributing to or influencing the statistical planning, design, conduct, analysis and reporting of trials. This protocol will describe the methodological approach taken for the following: conducting a systematic and comprehensive search for relevant articles, applying eligibility criteria for the inclusion of such articles, extracting data and information, appraising the quality of the articles, and thematically synthesizing the data to illuminate the key factors influencing statistical aspects of trials.
    Keywords Medicine ; R
    Subject code 306
    Language English
    Publishing date 2020-09-01T00:00:00Z
    Publisher F1000 Research Ltd
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  8. Article ; Online: An evaluation of the process of informed consent

    Lydia OSullivan / Laura Feeney / Rachel K. Crowley / Prasanth Sukumar / Eilish McAuliffe / Peter Doran

    Trials, Vol 22, Iss 1, Pp 1-

    views from research participants and staff

    2021  Volume 15

    Abstract: Abstract Background The process of informed consent for enrolment to a clinical research study can be complex for both participants and research staff. Challenges include respecting the potential participant’s autonomy and information needs while ... ...

    Abstract Abstract Background The process of informed consent for enrolment to a clinical research study can be complex for both participants and research staff. Challenges include respecting the potential participant’s autonomy and information needs while simultaneously providing adequate information to enable an informed decision. Qualitative research with small sample sizes has added to our understanding of these challenges. However, there is value in garnering the perspectives of research participants and staff across larger samples to explore the impact of contextual factors (time spent, the timing of the discussion and the setting), on the informed consent process. Methods Research staff and research participants from Ireland and the UK were invited to complete an anonymous survey by post or online (research participants) and online (research staff). The surveys aimed to quantify the perceptions of research participants and staff regarding some contextual factors about the process of informed consent. The survey, which contained 14 and 16 multiple choice questions for research participants and staff respectively, was analysed using descriptive statistics. Both surveys included one optional, open-ended question, which were analysed thematically. Results Research participants (169) and research staff (115) completed the survey. Research participants were predominantly positive about the informed consent process but highlighted the importance of having sufficient time and the value of providing follow-up once the study concludes, e.g. providing results to participants. Most staff (74.4%) staff reported that they felt very confident or confident facilitating informed consent discussions, but 63% felt information leaflets were too long and/or complicated, 56% were concerned about whether participants had understood complex information and 40% felt that time constraints were a barrier. A dominant theme from the open-ended responses to the staff survey was the importance of adequate time and resources. Conclusions Research ...
    Keywords Informed consent ; Clinical research ; Clinical trials ; Methodology ; Surveys and Questionnaires ; Medicine (General) ; R5-920
    Subject code 306
    Language English
    Publishing date 2021-08-01T00:00:00Z
    Publisher BMC
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  9. Article ; Online: Harmonising the human biobanking consent process

    Sarah Cooper / Tomás P. Carroll / Laura Gorman / Ann Cullen / Blánaid Mee / Billy McCann / Verena Murphy / Nicola Miller / Jackie O'Leary / Máiréad Murray / Niamh Clarke / Emma Snapes / Sharon O'Toole / Lydia O'Sullivan / Suzanne Bracken

    HRB Open Research, Vol

    an Irish experience [version 3; peer review: 2 approved]

    2022  Volume 4

    Abstract: Biobanks are repositories of human biological samples and data. They are an important component of clinical research in many disease areas and often represent the first step toward innovative treatments. For biobanks to operate, researchers need human ... ...

    Abstract Biobanks are repositories of human biological samples and data. They are an important component of clinical research in many disease areas and often represent the first step toward innovative treatments. For biobanks to operate, researchers need human participants to give their samples and associated health data. In Ireland, research participants must provide their freely given informed consent for their samples and data to be taken and used for research purposes. Biobank staff are responsible for communicating the relevant information to participants prior to obtaining their consent, and this communication process is supported by the Participant Information Leaflets and Informed Consent Form (PI/ICFs). PILs/ICFs should be concise, intelligible, and contain relevant information. While not a substitute for layperson and research staff discussions, PILs and ICFs ensure that a layperson has enough information to make an informed choice to participate or not. However, PILs/ICFs are often lengthy, contain technical language and can be complicated and onerous for a layperson to read. The introduction of the General Data Protection Regulation and the related Irish Health Research Regulation presented additional challenges to the Irish biobank community. In May 2019, the National Biobanking Working Group (NBWG) was established in Ireland. It consists of members from diverse research backgrounds located in universities, hospitals and research centres across Ireland and a public/patient partner. The NBWG aimed to develop a suite of resources for health research biobanks via robust and meaningful patient engagement, which are accessible, General Data Protection Regulation/Health Research Regulation-compliant and could be used nationally, including a PIL/ICF template. This open letter describes the process whereby this national biobank PIL/ICF template was produced. The development of this template included review by the Patient Voice in Cancer Research, led by Professor Amanda McCann at University College Dublin and the ...
    Keywords Biobanking ; Translational Research ; Genetic Research ; Clinical Research ; Participant Information Leaflet ; Informed Consent Form ; eng ; Medicine ; R
    Subject code 306
    Language English
    Publishing date 2022-01-01T00:00:00Z
    Publisher F1000 Research Ltd
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  10. Article ; Online: Preparing accessible and understandable clinical research participant information leaflets and consent forms

    Eleanor Coleman / Lydia O’Sullivan / Rachel Crowley / Moira Hanbidge / Seán Driver / Thilo Kroll / Aoife Kelly / Alistair Nichol / Orlaith McCarthy / Prasanth Sukumar / Peter Doran

    Research Involvement and Engagement, Vol 7, Iss 1, Pp 1-

    a set of guidelines from an expert consensus conference

    2021  Volume 11

    Abstract: Plain English summary Researchers must make sure that research participants are given all of the relevant information about a research study or trial. This information helps research people to decide if they wish to take part. The Participant Information ...

    Abstract Plain English summary Researchers must make sure that research participants are given all of the relevant information about a research study or trial. This information helps research people to decide if they wish to take part. The Participant Information Leaflet/Informed Consent Form is an important source of information for potential research participants and their families and friends. However, Participant Information Leaflets/Informed Consent Forms are often not easy for lay readers to understand. They can be especially difficult for readers with dyslexia or those who have problems with reading, or understanding numbers. There are guidelines available for designing information leaflets for lay readers, for example, leaflets about medicines or different health problems. But it would be helpful for researchers if these guidelines were applied to clinical research Participant Information Leaflets/Informed Consent Forms. We searched for and gathered guidance for designing and writing information leaflets for adult, lay readers and checked to see if the sources of the guidance were reliable. We then put together some recommendations for designing and writing information leaflets for research studies or trials. We formed an expert group, made up of both laypersons and researchers, who reviewed and discussed these recommendations. The expert group agreed on a final set of recommendations. We hope that these recommendations will help researchers to prepare Participant Information Leaflets/ Informed Consent Forms that are consistently easier to for participants to read and understand.
    Keywords Clinical research ; Clinical trials ; Informed consent ; Participant information leaflets ; Patient information leaflets ; Patient and public involvement ; Medicine ; R ; Medicine (General) ; R5-920
    Subject code 306
    Language English
    Publishing date 2021-05-01T00:00:00Z
    Publisher BMC
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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