Abstract: Increasing numbers of health organisations are offering some or all of their patients access to the visit notes housed in their electronic health records (so-called ’open notes’). In some countries, including Sweden and the USA, this innovation is advanced with patients using online portals to access their clinical records including the visit summaries written by clinicians. In many countries, patients can legally request copies of their records; however, open notes are different because this innovation offers patients rapid, real-time access via electronic devices. In this brief report, we explore what open notes might mean for placebo use in clinical care. Survey research into patient access to their clinical notes shows that increased transparency enhances patients’ understanding about their medications and augments engagement with their care. We reflect on the consequences of access for placebo prescribing, particularly for the common practice of deceptive placebo use, in which patients are not aware they are being offered a placebo. In addition, we explore how open notes might facilitate placebo and nocebo effects among patients. Bridging placebo studies with medical ethics, we identify a range of empirical research gaps that now warrant further study.
“Plain language summaries (PLS) of peer-reviewed medical journal publications are summaries of a piece of published literature that simplify highly-specialized terminology and jargon into language everyone can understand. PLS are intended for everyone engaging with medical research, such as patients, patient advocates, caregivers, healthcare professionals and policymakers. Frequently, they are brief, text-based lay abstracts formatted like, and hosted alongside, the scientific abstract. However, consensus on industry standards for PLS is still in its infancy, so other formats in use across the industry include multi-page visual infographics and digital enhancements, usually hosted in the supplementary materials or on third-party websites….
Why write a PLS?
Open science is a human right. Article 27 of the Universal Declaration of Human Rights states that “Everyone has the right freely to […] share in scientific advancement and its benefits”. The concept of open science as it relates to financial availability and open access publishing is already well established, and its principles can be seen in action in the likes of preprints, open source data sets, and open peer review reports, among others….
Accessible open science improves trust and transparency. At a time when public trust in the pharmaceutical industry is low, transparency is more important than ever, and what’s more transparent than sharing accurate and credible research directly with the public, in language they can understand?…
Our recommendations also call for PLS that are directly discoverable and findable instead of being buried in supplementary materials or multiple clicks away on third-party websites. PubMed is one of the most widely-used public databases of medical literature and already has an built-in function for hosting PLS. To be indexed on PubMed, a PLS needs to be text-based, 250 words or less, and tagged accordingly when uploaded by publishers. Therefore, the Open Pharma recommendations advise that PLS should meet these technical requirements. We do recognize, however, that PubMed is not an ideal platform for all stakeholders, and we would welcome future development of a central database for PLS that can match PubMed’s discoverability while providing more options for different content formats, such as infographics and videos to increase understanding and engagement….”
“Record numbers of people are taking part in health and social care research in the UK. Research brings huge benefits to patients and service users, with the findings ultimately leading to the prevention of ill health, earlier diagnosis, faster recovery and better outcomes.
However, if those research findings are not made public in a meaningful and timely way, we do those research participants a disservice. To really maximise and value the commitment of patients, service users and healthy volunteers who take part in research, transparency and openness are essential. It also means they are more likely to take part in future studies.
By disseminating research findings widely, we also enable further research and provide a strong evidence base for commissioning services and making health and care policy.
The Make it Public strategy signals an ambition to transform research transparency in the UK. Its vision for trusted information from health and social care research studies being publicly available for the benefit of all is one that we can all share. The Department of Health and Social Care is committed to the strategy and will continue to support the Health Research Authority (HRA) to make a real difference….”
“To better serve our readers and authors, we [JCRS Online Case Reports] will be moving to an Open Access publishing model, under a Creative Commons license to publish. The first step of this transition is to require signed consent from all patients included in case reports. Minor changes in the format of the abstract are also required.”
“If patients with mental illnesses are to be treated fairly in comparison with other categories of patients, they must be given access to promising experimental therapies, including psychedelics. The right of early access to promising therapies was advanced as an ethical principle by activist Larry Kramer during the AIDS pandemic, and has now largely been adopted by the medical establishment. Patients are regularly granted access to experimental drugs for many illness categories, such as cancer and infectious diseases. The need for expanded access is especially relevant during evolving crises like the AIDS and the coronavirus pandemics. In contrast to non-psychiatric branches of medicine, psychiatry has failed to expedite access to promising drugs in the face of public health emergencies, psychological crises, the wishes of many patients, and the needs of the community. Psychiatry must catch up to the rest of medicine and allow the preferences of patients for access to guide policy and law regarding unapproved medications like psychedelics….
Open questions include how to amplify the voices of patients regarding experimental therapies like psychedelics, how to implement early access, how to educate the public about this option once it exists, and how to ensure equitable access for multiple marginalized groups. A model of political engagement like ACT UP may not work for patients whose symptoms include lack of motivation and will, and who are at risk for re-traumatization. The authors are exploring an entirely patient-led counterpart to traditional academic peer review, which allows diverse patient communities to provide meaningful input into therapies that result from trials….”
“RIAT is an international effort to tackle bias in the way research is reported with the goal of providing more accurate information to patients and other healthcare decision makers.
Randomized controlled trials are known as medicine’s “gold standard” for reliable evidence. However, they are falling short of that standard, in large part due to two fundamental problems:
MISREPORTING: many trials that are published are inaccurately or incompletely reported (misreported trials)
INVISIBILITY: not all trials conducted are published (unpublished trials)
When the original investigators or sponsors do not correct misreporting, or even leave the entire trial unpublished, they can be considered to have abandoned their trial. And the downstream effects can be substantial, drawing to false conclusions about the effectiveness and safety of medical interventions.
The RIAT initiative aims to address these problems by offering a methodology that allows other people to responsibly correct the record….”
“I had a stroke half a decade ago and found I couldn’t access the medical literature on my extremely rare vascular condition.
I’m a capable reader, but I couldn’t get past the paywalls – which seemed absurd, given most research is publicly funded. While I had, already, long been an open access advocate by that point, this strengthened my resolve.
The public is often underestimated. Keeping research locked behind paywalls under the assumption that most people won’t be interested in, or capable of, reading academic research is patronising….
While this moral quandary should not be passed to young researchers, there may be benefits to them in taking a firm stance. Early career researchers are less likely to have grants to pay for article processing charges to make their work open access compared to their senior colleagues. Early career researchers are also the ones who are inadvertently paying the extortionate subscription fees to publishers. According to data from the Higher Education Statistics Agency (HESA), the amount of money UK universities fork out each year to access paywalled content from Elsevier – the largest academic publisher in the world – could pay 1,028 academic researchers a salary of £45,000 per year.
We know for-profit publishers, such as Elsevier, hold all the cards with respect to those prestigious titles. What we need are systematic “read and publish” deals that allow people to publish where they want without having to find funding for open access….
The current outlook for prospective researchers to secure an academic position at a university is compromised because so much money is spent propping up for-profit, commercial publishers. Rather than focusing on career damage to those who can’t publish with an Elsevier title, we should focus on the opportunity cost in hundreds of lost careers in academia….”
Data sharing is not common as part of biomedical publications
To increase data sharing biomedical journals, funders and academic institutions should introduce policies that will enhance data sharing and other open science practices
As part of research assessments incentives and rewards need to be introduced
Data sharing practices remain elusive in biomedicine. The COVID-19 pandemic has highlighted the problems associated with the lack of data sharing. The objective of this article is to draw attention to the problem and possible ways to address it.
Study Design and Setting
This article examines some of the current open access and data sharing practices at biomedical journals and funders. In the context of COVID-19 the consequences of these practices is also examined.
Despite the best of intentions on the part of funders and journals, COVID-19 biomedical research is not open. Academic institutions need to incentivize and reward data sharing practices as part of researcher assessment. Journals and funders need to implement strong polices to ensure that data sharing becomes a reality. Patients support sharing of their data.
Biomedical journals, funders and academic institutions should act to require stronger adherence to data sharing policies.
Abstract: Dissemination of research beyond the academic community is an ethical responsibility of researchers and necessary in translational research to help ensure the uptake of research findings to improve health outcomes. Often, partnerships between community and academicians do not include research dissemination plans, possibly reflecting researchers not knowing how to create these plans. This manuscript details the development process of a research dissemination training module for academicians and researchers. This training was conceptualized and developed by Core faculty and staff. Development steps were: (a) identifying researchers’ dissemination needs using the Core Investigator Survey; (b) identifying communities dissemination needs/preferences using feedback from our community advisory board; (c) conducting a literature search to identify dissemination concepts from researchers and community perspectives; (d) developing the training module; (e) conducting a cognitive review with one basic science researcher and one community-based participatory researcher; (f) evaluating the training; and (g) finalizing the training module. Training attendees included 1 clinical and 3 basic science clinical researchers, a biomedical postdoctoral fellow, and 10 research staff. Of those completing the feedback survey, 60% had some experience with research dissemination. As a result of training, more than 50% of respondents strongly agreed that as researchers they have a clear understanding of dissemination, a greater understanding of the dissemination process, how to identify stakeholders and successfully develop a dissemination plan. While disseminating research findings beyond academic publications may be new to some researchers, this training provided the tools to implement dissemination practices in their current and future research.
“While health systems and clinicians are increasingly aware of new federal rules1 that mandate offering patients access to the notes clinicians write in electronic health records (open notes), for many, and certainly for patients and their families, they come as a surprise. Taking effect April 5, 2021, the rules enact the bipartisan 21st Century Cures Act and aim to increase interoperability and ensure greater transparency in health care. Many health professionals support these goals but are anxious about how their practice and clinician-patient relationships may be affected. Stimulated in part by the OpenNotes movement,2 considerable anecdotal and research evidence is accumulating from the more than 250 health systems3 already sharing clinical notes with 55 million Americans registered on their electronic patient portals. More than 100 papers have been published dissecting the effects on care of this fundamental change in practice.2 What is being learned?”
“A main finding from resurveyed editors was that a combined 89% said there is no suitable formal role for patients as reviewers of medical literature. Asked to interpret prior results, 26% said that a lack of patient involvement may reflect a lag in acceptance and/or implementation of such processes overall, but more telling was that almost two-thirds (64%) maintained that drives to include patients in peer-reviewed journals’ editorial processes – unlike in drug development and/or clinical trial design – may need re-evaluation. That said, a number of editors did suggest that patients could serve valuable roles reviewing specific types of articles, for example, those dealing with adherence or quality of life….”
“Are you sick of health care systems not communicating with each other? Do you wish you could access more of your medical information — or your patients’ information — online? Do you ever wonder whether a health pattern you see is part of a larger trend? Two key developments have advanced the vision of seamless, secure exchange of electronic health records (EHRs) among health care institutions and patients.
That vision includes being able to learn from our data at a population scale. Through federal regulations issued this year, it will finally become reality in 2022. And the vision began at Boston Children’s Hospital more than a decade ago….”
“OpenNotes is the international movement promoting and studying transparent communication in healthcare. We help patients and clinicians share meaningful notes in medical records. We call these open notes….
OpenNotes is not software or a product. It’s a call to action.”
“Taking effect in April, 2021, rules implementing the bipartisan federal Cures Act specify that clinical notes are among electronic information that must not be blocked and must be made available free of charge to patients. To meet the interests of some patients, the rules allow specified exceptions….”
“Having worked to promote openness of research findings for some considerable time, it’s great to come across examples that illustrate why you’re making all the effort. The Journal of Patient Experience (published by the Association for Patient Experience/SAGE) uses a publication model that demonstrates an excellent use case for openness. This journal describes itself as: Giving voice to our patients and our providers, the Journal of Patient Experience (JPE) is an open access, peer-reviewed journal which focuses on presenting advances and applications that impact the patient experience….”