Abstract: Objectives To characterise the attitudes of Australians affected by cancer towards the sharing of de-identified research data with third parties, including the public.
Design, setting, participants Anonymous online survey between October 2022 and February 2023 of adult Australians previously diagnosed with cancer.
Main outcome measures Self-reported attitudes towards the sharing of human and non-human data, and the hypothetical sharing of their anonymised medical information and responses to the survey.
Results 551 respondents contributed data to the survey. There was strong support for cancer researchers sharing non-human and de-identified human research data with medical doctors (90% and 95% respectively) and non-profit researchers (both 94%). However, this declined when participants were asked whether data should be shared with for-profit researchers (both 64%) or posted publicly (both 61%). When asked if they would hypothetically consent to researchers at their treatment location collecting and sharing their de-identified data publicly, only half agreed (50%). In contrast, after being shown a visual representation of the de-identified survey data, 80% of respondents supported sharing it publicly. A further 10% also supported public sharing of some of the survey data, with the most frequently desired information to be withheld including education history and levels of trust in healthcare stakeholders.
Conclusions Australians affected by cancer support the sharing of research data, particularly with clinician and non-profit researchers. Visualisation of the data to be shared may also enhance support for making research data publicly available. These results should help alleviate any concerns about research participants’ attitudes on data sharing, as well as boost researchers’ motivation for sharing.
Abstract: Background/Aims Deidentified individual participant data (IPD) sharing has been implemented in the International Committee of Medical Journal Editors journals since 2017. However, there were some published clinical trials that did not follow the new implemented policy. This study examines the number of clinical trials that endorsed IPD sharing policy among top ophthalmology journals.
Method All published original articles in 2021 in 10 highest-ranking ophthalmology journals according to the 2020 journal impact factor were included. Clinical trials were determined by the WHO definition of clinical trials. Each article was then thoroughly searched for the IPD sharing statement either in the manuscript or in the clinical trial registry. We collected the number of published clinical trials that implemented IPD sharing policy as our primary outcome.
Results 1852 published articles in top 10 ophthalmology journals were identified, and 9.45% were clinical trials. Of these clinical trials, 44% had clinical trial registrations and 49.14% declared IPD sharing statements. Only 42 (48.83%) clinical trials were willing to share IPD, and 5 (10.21%) of these share IPD via an online repository platform. In terms of sharing period, 37 clinical trials were willing to share right after the publication and only 2 showed the ending of sharing period.
Conclusion This report shows that the number of clinical trials in top ophthalmology journals that endorsed the IPD sharing policy and the number of registrations is lower than half even though the policy has been implemented for several years. Future updates are necessary as policy evolves.
Data sharing policies should consider to whom benefits do and do not accrue.
Community Engaged Research Principles would increase community benefit.
Funders should develop mechanisms to ensure community benefit from data sharing.
Funders should track impact of data sharing on community-relevant outcomes….”
“Pharmaceutical companies need to regularly communicate to patients all essential information about their medicines, especially data from the research studies that were conducted to evaluate the medicine’s benefits and risks. To do that, companies will need to make sure patients have access to and awareness of relevant information. This can be achieved by ensuring medical information is freely available to the reader, and working with publishers to facilitate open access (free) publications. Companies should also help improve patients’ understanding of medical terminology, offer simplified versions of scientific content, and deliver information through various formats (print versus digital, text versus audio versus video) to address different learning styles and literacy levels. This will empower patients with knowledge and improve shared decision-making. It will also be essential for pharmaceutical companies to involve patients in various stages of medicine development, such as getting their input on how the research studies for investigating these medicines are designed and reported to ensure relevant information to patients are well-captured and clear. This should also go in parallel with providing opportunities to elevate the patient voice through patient-partnered research and authorship on topics particularly relevant to them.”
Abstract: Introduction Despite growing interest among patient and public partners to engage in writing lay summaries, evidence is scarce regarding the availability of resources to support them. This protocol describes the process of conducting a scoping review to: (1) summarise the source, criteria and characteristics, content, format, intended target audience, patient and public involvement in preparing guidance and development processes in the available guidance for writing lay summaries; (2) contextualise the available guidance to the needs/preferences of patient and public partners and (3) create a patient and public partner-informed output to support their engagement in writing lay summaries.
Method and analysis A scoping review with an integrated knowledge translation approach will be used to ensure the collaboration between patient/public partners and researchers in all steps of the review. To meet objective 1, the English language evidence within a healthcare context that provides guidance for writing lay summaries will be searched in peer-reviewed publications and grey literature. All screening and extraction steps will be performed independently by two reviewers. Extracted data will be organised by adapting the European Union’s principles for summaries of clinical trials for laypersons. For objectives 2 and 3, a consultation exercise will be held with patient and public partners to review and contextualise the findings from objective 1. A directed content analysis will be used to organise the data to the needs of the public audience. Output development will follow based on the results.
Ethics and dissemination Ethics approval will be obtained for the consultation exercise. Our target audience will be stakeholders who engage or are interested in writing lay summaries. Our dissemination products will include a manuscript, a lay summary and an output to support patient and public partners with writing lay summaries. Findings will be published in a peer-reviewed journal and presented at relevant conferences.
“The National Institutes of Health’s All of Us Research Program has begun returning personalized health-related DNA results to more than 155,000 participants, with reports detailing whether participants have an increased risk for specific health conditions and how their body might process certain medications. This marks a major milestone for the program, delivering on its promise to share information and return value to participants….”
Abstract: Covid-19 research made it painfully clear that the scandal of poor medical research, as denounced by Altman in 1994, persists today. The overall quality of medical research remains poor, despite longstanding criticisms. The problems are well known, but the research community fails to properly address them. We suggest that most problems stem from an underlying paradox: although methodology is undeniably the backbone of high-quality and responsible research, science consistently undervalues methodology. The focus remains more on the destination (research claims and metrics) than on the journey. Notwithstanding, research should serve society more than the reputation of those involved. While we notice that many initiatives are being established to improve components of the research cycle, these initiatives are too disjointed. The overall system is monolithic and slow to adapt. We assert that top-down action is needed from journals, universities, funders and governments to break the cycle and put methodology first. These actions should involve the widespread adoption of registered reports, balanced research funding between innovative, incremental and methodological research projects, full recognition and demystification of peer review, improved methodological review of reports, adherence to reporting guidelines, and investment in methodological education and research. Currently, the scientific enterprise is doing a major disservice to patients and society.
“Such a situation, while personally troubling, highlights the importance of open access medical research. I have been blessed to easily be able to get access to much high-quality, open medical research on this condition. Patients are most empowered when they have as much information as possible about their illnesses and I feel fortunate that open access in the medical disciplines has come this far. But, of course, there is still a road to travel. I will probably become a case study since there is not much information on this condition in a non-transplant patient. But this case study might not end up being open access research. As one of my friends put it, there’s “nothing like the warm glow of knowing your health problems have contributed to a paywalled PDF” …
But what I hope is that we find less damaging economic models than the article and book processing charges that have come to dominate. So-called “diamond” open access models, such as those that the team and I have pioneered at the Open Library of Humanities, offer equitable routes to open publishing and appear popular with academic libraries and academics. But such models are endangered by the continued dominance of massive commercial players and their transformative agreements, which threaten to consume entire library budgets in one fell swoop.
On the one hand, I continue to feel personally opposed to the Big Business model of academic publishing in which large corporations extract massive profits and restrict the free and open flow of research. On the other hand, I am concerned by some of the austerity logics that come out of the open access movement and that devalue all publisher labour. As I wrote at the close of Open Access and the Humanities, almost a decade ago now: “Publishers perform necessary labour that must be compensated and any new system of dissemination, such as open access, will require an entity to perform this labour, even if that labour takes a different form at different levels of compensation”. Striking the right balance here through equitable economic models is the terrain on which the future battle of open access will be fought.”
Abstract: Objective: The open science movement seeks to make research more transparent, and to that end, researchers are increasingly expected or required to archive their data in national repositories. In qualitative trauma research, data sharing could compromise participants’ safety, privacy, and confidentiality because narrative data can be more difficult to de-identify fully. There is little guidance in the traumatology literature regarding how to discuss data-sharing requirements with participants during the informed consent process. Within a larger research project in which we interviewed assault survivors, we developed and evaluated a protocol for informed consent for qualitative data sharing and engaging participants in data de-identification. Method: We conducted qualitative interviews with N = 32 adult sexual assault survivors regarding (a) how to conduct informed consent for data sharing, (b) whether participants should have input on sharing their data, and (c) whether they wanted to redact information from their transcripts prior to archiving. Results: No potential participants declined participation after learning about the archiving mandate. Survivors indicated that they wanted input on archiving because the interview is their story of trauma and abuse and it would be disempowering not to have control over how this information was shared and disseminated. Survivors also wanted input on this process to help guard their privacy, confidentiality, and safety. None of the participants elected to redact substantive data prior to archiving. Conclusions: Engaging participants in the archiving process is a feasible practice that is important and empowering for trauma survivors. (PsycInfo Database Record (c) 2022 APA, all rights reserved)
“Patients now have access to their own medical notes, which is surely progress. More patients are now taking advantage of the ability to view all of the coded information in their GP record online—and this November they’ll have access to all of the free text written in the consultation from that date onwards….
But there are unintended consequences. One is the increased demand for explanations….
As junior doctors, we learn that everything we write in a patient’s notes may potentially be read by them and that we should be polite and objective, backing up opinions with evidence. I may note mismatches between symptoms and signs when my patient who says that she’s fine has nevertheless objectively lost weight, or when the child with dreadful tummy ache clambers energetically onto my couch to be examined. In the past only a handful of patients ever asked to read their notes, but many GPs will have experienced protracted conversations with patients who were unhappy with the contents. In the future, when patients have routine access to everything we write, I fear that I may have to spend more time explaining my record of the consultation….
More fundamentally, if there’s a high likelihood that all notes will be viewed online, will GPs stop noting their “soft concerns” that are so vital in both child and adult safeguarding?…”
“Gold Open Access under a Creative Commons licence is arguably a major way in which you can increase the reach of your work because most clinicians or patients cannot access paywalled content. If you submit to a subscription publisher, you will have the option of paying the article processing charge (APC) so that your work becomes Gold Open Access. This is expensive for most individuals and your funder or institution may pay the APC on your behalf – but you must ask. You can also ask the journal if other forms of Open Access are appropriate or possible (Table?1). Next, you can approach your department, institution or university to see what promotion it can offer. Sometimes, the journal may have declined to issue a press release, but others still might believe your work to be newsworthy. Authors could even approach newspapers, radio stations, broadcasters and journalists independently. Finally, you may wish to approach blog and podcast producers, conference organisers and social media influencers. The more methods used to communicate key messages from your work, the higher the reach of your paper….”
“Rapid communication of clinical trial results has likely saved lives during the COVID-19 pandemic and should become the new norm….
But during health emergencies, there are many tensions, one of which is the mismatch between the urgent need for information and evidence and the much longer time frames of scientific peer review and publication. The COVID-19 pandemic is the first global health emergency of the new information age, with data and results widely shared via social media. This has resulted in very real difficulties in distinguishing important information from noise, and real news from fake news. How should the research and medical community best manage this new reality?…
Some may argue that the speed advantage of preprints does not outweigh the risks of poor-quality, misleading or even fraudulent research being published and acted upon. I would counter that clinicians should not rely solely on peer review to assess the validity and meaningfulness of research findings. This is because dubious, perhaps fraudulent data can still get through peer review, as was seen with early COVID papers published and then retracted from two of the most prestigious medical journals. In addition, even valid data can be misleading. There has been an avalanche of observational data that passed peer review and was then used to justify treatments, most notably with hydroxychloroquine, but the susceptibility of observational methodology to moderate biases means that such data should not be the basis of patient care.
I take two lessons from our experience running the largest COVID-19 clinical trial over the last two years. The first is that that the preprint system has come of age, demonstrating huge value in rapidly communicating important research findings. Almost daily I am alerted through social media alerts from trusted sources and colleagues of important new findings published as preprints. A degree of immediate peer review is also available by means of the preprint comments section and from colleagues via social media. The full peer-reviewed manuscripts usually appear many weeks or even months later. I cannot envisage a future without such rapid dissemination of new evidence.
Given this new reality, the second lesson is that we must ensure that the medical community and policy makers are sufficiently skilled in critical thinking and scientific methods that they can make sensible decisions, regardless of whether an article is peer reviewed or not.”
Abstract: The development of a patient-centered approach to medicine is gradually allowing more patients to be involved in their own medical decisions. However, this change is not happening at the same rate in clinical research, where research generally continues to be carried out on patients, but not with Patients. This work describes the why, when, and how of more active patient participation in the research process. Specific measures are proposed to improve patient involvement in 1) setting priorities, 2) study leadership and design, 3) improved access to clinical trials, 4) preparation and oversight of the information provided to participants, 5) post-study evaluation of the patient experience, and 6) the dissemination and application of results. In order to achieve these aims, the relative emphases on the ethical principles underlying research need to be changed. The current model based on the principle of beneficence must be left behind, and one that upholds the ethical principles of autonomy and non maleficence should be embraced. There is a need to improve the level of information that patients and society as a whole have on research objectives and processes; the goal is to promote the gradual emergence of the expert patient.
From the body of the paper: “According to some surveys, ?95% of patients and members of IRBs believe that patients should be informed of the results of the research study. Nevertheless, this is a fairly uncommon practice, and the usual situation is that after participating in a study, patients are not notified of the results.”
The aims of the study were to identify publicly available patient safety report databases and to determine whether these databases support safety analyst and data scientist use to identify patterns and trends.
An Internet search was conducted to identify publicly available patient safety databases that contained patient safety reports. Each database was analyzed to identify features that enable patient safety analyst and data scientist use of these databases.
Seven databases (6 hosted by federal agencies, 1 hosted by a nonprofit organization) containing more than 28.3 million safety reports were identified. Some, but not all, databases contained features to support patient safety analyst use: 57.1% provided the ability to sort/compare/filter data, 42.9% provided data visualization, and 85.7% enabled free-text search. None of the databases provided regular updates or monitoring and only one database suggested solutions to patient safety reports. Analysis of features to support data scientist use showed that only 42.9% provided an application programing interface, most (85.7%) provided batch downloading, all provided documentation about the database, and 71.4% provided a data dictionary. All databases provided open access. Only 28.6% provided a data diagram.
Patient safety databases should be improved to support patient safety analyst use by, at a minimum, allowing for data to be sorted/compared/filtered, providing data visualization, and enabling free-text search. Databases should also enable data scientist use by, at a minimum, providing an application programing interface, batch downloading, and a data dictionary.
Abstract: What research practices should be considered acceptable? Historically, scientists have set the standards for what constitutes acceptable research practices. However, there is value in considering non-scientists’ perspectives, including research participants’. 1873 participants from MTurk and university subject pools were surveyed after their participation in one of eight minimal-risk studies. We asked participants how they would feel if (mostly) common research practices were applied to their data: p-hacking/cherry-picking results, selective reporting of studies, Hypothesizing After Results are Known (HARKing), committing fraud, conducting direct replications, sharing data, sharing methods, and open access publishing. An overwhelming majority of psychology research participants think questionable research practices (e.g. p-hacking, HARKing) are unacceptable (68.3–81.3%), and were supportive of practices to increase transparency and replicability (71.4–80.1%). A surprising number of participants expressed positive or neutral views toward scientific fraud (18.7%), raising concerns about data quality. We grapple with this concern and interpret our results in light of the limitations of our study. Despite the ambiguity in our results, we argue that there is evidence (from our study and others’) that researchers may be violating participants’ expectations and should be transparent with participants about how their data will be used.