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PLOT-IT Public Led Online Trials Infrastructure and Tools

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Amy Price
added 2 research items
Objective Many journals permit authors to submit supplementary material for publication alongside the article. We explore the value, use and role of this material in biomedical journal articles from the perspectives of authors, peer reviewers and readers. Design and setting We conducted online surveys (November–December 2016) of corresponding authors and peer reviewers at 17 BMJ Publishing Group journals in a range of specialities. Participants Participants were asked to respond to one of three surveys: as authors, peer reviewers or readers. Results We received 2872/20340 (14%) responses: authors 819/6892 (12%), peer reviewers 1142/6682 (17%) and readers 911/6766 (14%). Most authors submitted (711/819, 87%) and 80% (724/911) of readers reported reading supplementary material with their last article, while 95% (1086/1142) of reviewers reported seeing these materials sometimes. Additional data tables were the most common supplementary material reported (authors: 74%; reviewers: 89%; readers: 67%). A majority in each group indicated additional tables were most useful to readers (61%–77%); 20%–36% and 3%–4% indicated they were most useful to peer reviewers and journal editors, respectively. Checklists and reporting guidelines showed the opposite: higher proportions of each group regarded these as most useful to journal editors. All three groups favoured the publication of additional tables and figures on the journal’s website (80%–83%), with <4% of each group responding that these do not need to be available. Approximately one-fifth (16%–23%) responded that raw study data should be available on the journal’s website, while 24%–33% said that these materials should not be made available anywhere. Conclusions Authors, peer reviewers and readers agree that supplementary materials are useful. Supplementary tables and figures were favoured over reporting checklists or raw data for reading but not for study replication. Journals should consider the roles, resource costs and strategic placement of supplementary materials to ensure optimal usage and minimise waste. Trial registration number NCT02961036 .
Amy Price
added a research item
O19 Developing resources for a learner-centred approach to learning and development for public involvement in research Lucy Frith1, Bernard Gudgin2, Amander Wellings3 1National Institute for Health Research (NIHR), Research Design Service North West, University of Liverpool, Liverpool, UK; 2Public representative, Thames Valley, UK; 3Public representative, Norfolk, UK Correspondence: Lucy Frith (L.J.Frith@liverpool.ac.uk) In 2015 the National Institute for Health Research (NIHR) ‘Going the Extra Mile’ report highlighted the need to improve support for learning and development, which was reiterated in an NIHR-wide Learning & Development Working Group report of 2015 [1]. Despite widespread training activity, resources that support members of the public, researchers and public involvement managers can be difficult to find, and opportunities often are insufficiently promoted or duplicated. The INVOLVE Learning and Development Project Group was formed in 2016 to improve the resources and support available for learning and development. Consisting of public members, and public involvement leads from the charity sector and a variety of NIHR organisations, the Group took a collaborative approach and formed six sub-groups to address: individuals’ learning needs; inductions; how opportunities are promoted and accessed; how to share learning about engaging diverse communities; how resources are shared across websites; and top tips to promote good practice. Developing resources in these areas will allow individuals to assess their own skills and knowledge, how this relates to the needs of their role, and what areas require development. Improved information at inductions will benefit those new to research or involvement, and better accessibility of learning opportunities will prevent existing duplication. This presentation will include an interactive session during which delegates will use some of the new learner-centred resources. By the end of the session, delegates will have an understanding of the resources available, where they can be found and how they might be used to support their own (and others’) development. Acknowledgements This presentation will be delivered on behalf of the INVOLVE Learning and Development Project Group. References 1. INVOLVE (2015) NIHR-wide learning and development for public involvement: working group report and recommendations, INVOLVE: Eastleigh. Publication link: http://www.invo.org.uk/wp-content/uploads/2016/03/FINAL-NIHR-LD-report-July-2015.pdf
Amy Price
added a research item
Background: In this study, we demonstrate a collective collaborative, conversational, pre-publication peer review of a randomized controlled trial. Methods: Using Critical Appraisal Skills Programme checklist, a group of research-oriented undergraduate medical and pharmacy students and their teacher collectively on an online forum, discuss and review a randomized controlled trial submitted to the Annals of Neurosciences and the explanatory commentary from each reviewer makes a basic scaffold for critical appraisal of the manuscript. Results: This method provided the opportunity for students to engage in online interactive training and allowed them to understand tools used for critical appraisal of a study. Students were incentivized by the potential publication credit and they look forward to continuing this work and perhaps providing one small step to making medical education more interactive. Conclusion: Open peer review involving a group of reviewers at a time produces multidirectional reviewing concepts, thus helps to improve the quality of paper and also may reduce the time between review and publication.
Amy Price
added a research item
Objectives While documented plans for patient and public involvement (PPI) in research are required in many grant applications, little is known about how frequently PPI occurs in practice. Low levels of reported PPI may mask actual activity due to limited PPI reporting requirements. This research analysed the frequency and types of reported PPI in the presence and absence of a journal requirement to include this information. Design and setting A before and after comparison of PPI reported in research papers published in The BMJ before and 1 year after the introduction of a journal policy requiring authors to report if and how they involved patients and the public within their papers. Results Between 1 June 2013 and 31 May 2014, The BMJ published 189 research papers and 1 (0.5%) reported PPI activity. From 1 June 2015 to 31 May 2016, following the introduction of the policy, The BMJ published 152 research papers of which 16 (11%) reported PPI activity. Patients contributed to grant applications in addition to designing studies through to coauthorship and participation in study dissemination. Patient contributors were often not fully acknowledged; 6 of 17 (35%) papers acknowledged their contributions and 2 (12%) included them as coauthors. Conclusions Infrequent reporting of PPI activity does not appear to be purely due to a failure of documentation. Reporting of PPI activity increased after the introduction of The BMJ’s policy, but activity both before and after was low and reporting was inconsistent in quality. Journals, funders and research institutions should collaborate to move us from the current situation where PPI is an optional extra to one where PPI is fully embedded in practice throughout the research process.
Amy Price
added a research item
Background: Funders encourage lay-volunteer inclusion in research. There are controversy and resistance, given concerns of role confusion, exploratory methods, and limited evidence about what value lay-volunteers bring to research. This overview explores these areas. Methods: Eleven databases were searched without date or language restrictions for systematic reviews of public and patient involvement (PPI) in clinical trials design. This systematic overview of PPI included 27 reviews from which areas of good and bad practice were identified. Strengths, weaknesses, opportunities, and threats of PPI were explored through use of meta-narrative analysis. Results: Inclusion criteria were met by 27 reviews ranging in quality from high (n = 7), medium (n = 14) to low (n = 6) reviews. Reviews were assessed using CERQUAL NICE, CASP for qualitative research and CASP for systematic reviews. Four reviews report risk of bias. Public involvement roles were primarily in agenda setting, steering committees, ethical review, protocol development, and piloting. Research summaries, follow-up, and dissemination contained PPI, with lesser involvement in data collection, analysis, or manuscript authoring. Trialists report difficulty in finding, retaining, and reimbursing volunteers. Respectful inclusion, role recognition, mutual flexibility, advance planning, and sound methods were reported as facilitating public involvement in research. Public involvement was reported to have increased the quantity and quality of patient relevant priorities and outcomes, enrollment, funding, design, implementation, and dissemination. Challenges identified include lack of clarity within common language, roles, and research boundaries, while logistical needs include extra time, training, and funding. Researchers report struggling to report involvement and avoid tokenism. Conclusions: Involving patients and the public in clinical trials design can be beneficial but requires resources, preparation, training, flexibility, and time. Issues to address include reporting deficits for risk of bias, study quality, and conflicts of interests. We need to address these tensions and improve dissemination strategies to increase PPI and health literacy.
Amy Price
added 2 research items
ABSTRACT Introduction :Evidence-based medicine (EBM) introduced in 1991 marks the relationship between medical evidence and clinical practice. In EBM, evidence acts as a neutral arbiter between competing views. EBM enjoys exponential growth on par with innovations such as antibiotics and anesthesia, however it has not escaped external controversy or internal debate. EBM asserts the trustworthiness of available evidence can determine the confidence we place in the relevant evidence. Crucially evidence is dynamic and comes in gradation of its relationship to the “truth”- high quality evidence is considered closer to the truth than lower quality evidence. The global reach of the concept of EBM implies it is commensurable or common across languages. Objective: To investigate how the term “Evidence" is interpreted across languages and to explore the value of a common definition for the word evidence across languages and cultures. Methods: To assess how “evidence” is translated across 90 languages, we used Google Translator to translate the term evidence. After obtaining translation of the term “evidence”; we reversed translation to assess variation in how the term “evidence was denoted. We confirmed reliability of the "Google translation" by polling EBM colleagues for whom these languages were their mother tongue. Results: We found languages carry distinctly different terms from the meaning of “evidence” in English. In 79/90 or 88% of languages, evidence and proof were used interchangeably and interpreted as "proof, law or terms that disallow grading of evidence quality and minimize the importance of critical appraisal. Conclusions Most languages translate “evidence” as a proof – a distinct concept that assumes certainty in arriving at “conclusion” than what English word “evidence” presumes. The concepts of medical evidence and, thus, EBM are arguably shaped by translation. Adopting the term "evidence" within a language does not retain or assure that the concept of EBM is commensurable or common across languages. When it is stated practice and policy are evidence-based, we benefit from the clarification of what is meant by evidence.
Amy Price
added a research item
Background, Aims and Objectives: Participants in health research want to be involved in the research. Researchers struggle with how to approach citizens as co-researchers, train them, tactfully reduce contributions that are less useful and what to do about compensation and where to include citizen input in a manuscript. The aim of this study was to use participatory action research to prioritize the research question and to explore projected solutions as citizens and researchers with equal voices in research. In the first section of this paper we provide an introductory explanation of Participatory Action. In the second section we discuss our findings. Methods: The research explored the strengths, weaknesses, opportunities and threats in clinical trials as represented through online communications. In this follow-up analysis we share learning points for successful research involvement. Researchers and citizens worked in a participatory research framework. They searched the Internet using keywords to locate social media conversations and Internet interviews about clinical trials over 4 months until a saturation point was reached. Data were de-identified and coded into a SWOT analysis and further coded into themes and analyzed. The findings and solutions were discussed using a circle chart for problem-solving. The data were prioritized by consensus and the process is reported here. Results: Investigators and participant researchers were not conflicted in assigning themes because the data were clearly stated and the same sentiments were repeated consistently. The teams reached consensus about which quotes to include to support the findings. These themes ranged from supportive researcher-to-participant and participant-peer relationships to experiences of shame, research disparity, intimidation and personal loss. Conclusions: This research engages citizen participants as equal partners in all aspects of this study. Public and patient involvement as co-production in research can be used to identify and suggest resolutions in research. The use of participatory action in research can improve consistency, communication, innovation and quality in clinical trials.
Amy Price
added a research item
BACKGROUND The use of public engagement and self-management in online clinical trials is growing with benefits, boundaries and minimal methodological guidance. This analysis explores whether running self-recruited online trials can provide trustworthy and useful answers to research questions. AIM To systematically explore existing self-recruited online randomized controlled trials of self-management interventions and analyze the trials to assess their strengths and weaknesses, the quality of trials reporting and to report how participants were involved in the research process. METHODS The Online Randomized Controlled Trials of Health Information Database (ORCHID) will be used as a sampling framework to identify a subset of self-management self-recruited interventions. The trials will be used to explore the qualities of self-recruited online randomized controlled trials and to evaluate how useful they are for obtaining trustworthy answers to questions about health self-management and citizen research involvement. This research employs participatory action research where researchers and participants work as collaborators. SUMMARY This analysis can provide an overall view of effective methods for online trials and to provide insights into integration for online trials development as early as the protocol planning stage. FEEDBACK We would appreciate, insights, practical ideas, and suggestions to make this research better. Comments or email welcome. Amy Healingjia@msn.com and we will look for ways to integrate your feedback into our research plan.
Amy Price
added 19 research items
To share how an effectual merging of local and online networks in low resource regions can supplement and strengthen the local practice of patient centered care through the use of an online digital infrastructure powered by all stakeholders in healthcare. User Driven Health Care offers the dynamic integration of patient values and evidence based solutions for improved medical communication in medical care. This paper conceptualizes patient care-coordination through the lens of engaged stakeholders using digital infrastructures tools to integrate information technology. We distinguish this lens from the prevalent conceptualization of dyadic ties between clinician-patient, patient-nurse, clinician-nurse, and offer the holistic integration of all stakeholder inputs, in the clinic and augmented by online communication in a multi-national setting. We analyze an instance of the user-driven health care (UDHC), a network of providers, patients, students and researchers working together to help manage patient care. The network currently focuses on patients from LMICs, but the provider network is global in reach. We describe UDHC and its opportunities and challenges in care-coordination to reduce costs, bring equity, and improve care quality and share evidence. UDHC has resulted in coordinated global based local care, affecting multiple facets of medical practice. Shared information resources between providers with disparate knowledge, results in better understanding by patients, unique and challenging cases for students, innovative community based research and discovery learning for all.
Background: Online trials are rapidly growing in number, offering potential benefits but also methodological, ethical and social challenges. The International Network for Knowledge on Well-being (ThinkWell™) aims to increase public and patient participation in the prioritisation, design and conduct of research through the use of technologies. Objective: We aim to provide a baseline understanding of the online trial environment, determining how many trials have used internet-based technologies; how they have been used; and how use has developed over time. Methods: We searched a range of bibliographic databases to March 2015, with no date limits, supplemented by citation searching and references provided by experts in the field. Results were screened against inclusion and exclusion criteria, and included studies mapped against a number of key dimensions, with key themes developed iteratively throughout the process. Results: We identified 1992 internet-based trials to March 2015. The number of reported studies increased substantially over the study timeframe. The largest number of trials were conducted in the USA (49.7%), followed by The Netherlands (10.2%); Australia (8.5%); the United Kingdom (5.8%); Sweden (4.6%); Canada (4%); and Germany (2.6%). South Korea (1.5%) has the highest number of reported trials for other continents. There is a predominance of interventions addressing core public health challenges including obesity (8.6%), smoking cessation (5.9%), alcohol abuse (7.7%) and physical activity (10.2%); in mental health issues such as depression (10.9%) and anxiety (5.6%); and conditions where self-management (16.6%) or monitoring (8.1%) is a major feature of care. Conclusions: The results confirm an increase in the use of the internet in trials. Key themes have emerged from the analysis and further research will be undertaken in order to investigate how the data can be used to improve trial design and recruitment, and to build an open access resource to support the public-led research agenda.
This is the protocol for a review and there is no abstract. The objectives are as follows: To assess the effects of drinking extra water or other non-caloric beverages for promoting weight loss or preventing weight gain.