Patients find misleading information on the internet

October 30, 2018

Pär SegerdahlIn phase 1 clinical studies of substances that might possibly be used to treat cancer in the future, cancer patients are recruited as research participants. These patients almost always have advanced cancer that no longer responds to the standard treatment.

That research participation would affect the cancer is unlikely. The purpose of a phase 1 study is to determine safe dosage range and to investigate side effects and other safety issues. This will then enable proceeding to investigating the effectiveness of the substance on specific forms of cancer, but with other research participants.

Given that patients often seek online information on clinical trials, Tove Godskesen, Josepine Fernow and Stefan Eriksson wanted to investigate the quality of the information that currently is available on the internet about phase 1 clinical cancer trials in Sweden, Denmark and Norway.

The results they report in the European Journal of Cancer Care are quite alarming. The most serious problem, as I understand it, is that the information conceals risks of serious side effects, and in various ways suggests possible positive treatment outcomes. This lack of accurate language is serious. We are dealing with severely ill patients who easily entertain unrealistic hopes for new treatment options.

To give a picture of the problem, I would like to give a few examples of typical phrases that Godskesen, Fernow and Eriksson found in the information on the internet, as well as their suggestions for more adequate wordings. Noticing the contrast between the linguistic usages is instructive.

One problem is that the information speaks of treatment, even though it is about research participation. Instead of writing “If you are interested in the treatment,” you could write “If you want to participate in the research.” Rather than writing “Patients will be treated with X,” you could write “Participants will be given X.”

The substance being tested is sometimes described as a medicine or therapy. Instead, you can write “You will get a substance called X.”

Another problem is that research participation is described as an advantage and opportunity for the cancer patient. Instead of writing “An advantage of study participation is that…,” one could write “The study might lead to better cancer treatments for future patients.” Rather than writing “This treatment could be an opportunity for you,” which is extremely misleading in phase 1 clinical cancer trials, one could more accurately say, “You can participate in this study.”

The authors also tested the readability of the texts they found on the internet. The Danish website skaccd.org had the best readability scores, followed by the Norwegian site helsenorge.no. The Swedish website cancercenter.se got the worst readability scores. The information was very brief and deemed to require a PhD to be understandable.

It is, of course, intelligible that it is hard to speak intelligibly about such difficult things as cancer trials. Not only do the patients recruited as study participants hope for effective treatment. The whole point of the research is effective cancer treatment. This is the ultimate perspective of the research; the horizon towards which the gaze is turned.

The fact, however, is that this horizon is far removed, far away in the future, and is about other cancer patients than those who participate in phase 1 trials. Therefore, it is important not to let this perspective characterize information to patients in whom hope would be unrealistic.

Do not talk about treatments and opportunities. Just say “You can participate in this study.”

Pär Segerdahl

Godskesen, TE, Fernow J, Eriksson S. Quality of online information about phase I clinical cancer trials in Sweden, Denmark and Norway. Eur J Cancer Care. 2018;e12937. https://doi.org/10.1111/ecc.12937

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Genetic risk: Should researchers let people know?

September 24, 2018

Should researchers inform research participants if they happen to discover individual genetic risks of disease? Yes, many would say, if the information is helpful to the participants. However, the value of complex genetic risk information for individuals is uncertain. Jennifer Viberg Johansson suggests that this uncertainty needs to be acknowledged by both geneticists and ethicists.

One reason people want to participate in large genetic studies is the comprehensive health checks researchers often offer to collect data. In the future, people could also be offered information about genetic risks. According to Jennifer Viberg Johansson, there are some factors researchers should consider before offering these kinds of results.

Providing genetic risk information may not be as helpful to individuals as one may think. Knowing your genetic make-up is not the same as knowing your own probability for disease. In addition, the genetic risk information from research is not based on symptoms or personal concerns, as it would be in the healthcare system. It is thus less “personalised” and not connected to any symptoms.

Genetic risk information is complex and can be difficult to understand. To the research participants interviewed by Jennifer Viberg Johansson, risk information is something that offers them an explanation of who they are, where they are from, and where they may be heading. To them, learning about their genetic risk is an opportunity to plan their lives and take precautions to prevent disease.

Whether research participants want genetic risk information or not is more complex. Research participants themselves may change their answer depending on the way the question is asked. Risk research shows that we interpret probabilities differently, depending on the outcome and consequences. Jennifer Viberg Johansson’s work points in the same direction: probability is not an essential component of people’s decision-making when there are ways to prevent disease.

People have difficulties making sense of genetic risk when it is presented in the traditional numeric sense. It is hard to interpret what it means to have a 10 per cent or 50 per cent risk of disease. Instead, we interpret genetic risk as a binary concept: you either have risk, or you don’t. Based on her results, Jennifer Viberg Johansson suggests we keep this in mind for genetic counselling. We need to tailor counselling to people’s often binary perceptions of risk.

Communicating risk is difficult, and requires genetic counsellors to understand how different people understand the same figures in different ways.

Jennifer Viberg Johansson defended her dissertation September 21, 2018.

Anna Holm

Viberg Johansson J., (2018), INDIVIDUAL GENETIC RESEARCH RESULTS – Uncertainties, Conceptions, and Preferences, Uppsala: Acta Universitatis Upsaliensis

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What does the order of authors mean?

September 19, 2018

Pär SegerdahlHow should we interpret the sequence of author names in academic publications? Does it inform us about how much each author contributed to the publication?

After reading an article on the topic by Gert Helgesson and Stefan Eriksson, I realize that authorship order is a very disorderly matter. The first and last positions are often counted as the most important. But not always. To my surprise, not even a first position necessarily signifies first authorship. Sometimes, the asterisk after the author whose contact details are given is interpreted as a sign of first authorship. Sometimes the asterisk means that this author is subordinate and handles all practicalities associated with the publication.

Sometimes the second position is of particular importance. Sometimes not. Sometimes the next to last position has a particular interpretation. Sometimes another. Helgesson and Eriksson talk about group traditions and describe conventions in different scientific fields. Are there really no guidelines to follow? No, actually not. Author guidelines at most recommend authors to agree well in advance on the order of authors. However, since the guidelines do not specify what the order signifies, the meaning of the agreed upon authorship order is unclear!

Considering how meritorious authorship is in academic competition for positions and grants, this lack of order is surprising. Is the question too sensitive? Will an overly clear order lead to time-consuming quarrels between authors about who should stand first, last, second place, second to last, with asterisk, without asterisk, and so forth?

Helgesson and Eriksson discuss different proposals for clarifying authorship order. One proposal they encountered is that the first and last positions each render 40% of the total value of the paper. The remaining 20% ​​is shared equally by the authors in the intermediate positions. For five authors, authorship value would thus be divided: 40, 6.7, 6.7, 6.7 and 40%. This type of proposal is dismissed, because fixed values ​​would be fair only if work efforts actually happened to be distributed just that way (which is unlikely).

A more flexible system could be to provide actual percentages, on a case-by-case basis. But how are actual percentages determined? Different authors contribute qualitatively differently: by designing the study; by analyzing data; by drafting the paper. What kind of contribution has most weight?

Another suggestion is not to assign a relative value to the authors’ contributions. Instead, one specifies what each one contributed. Contributorship instead of authorship, where the contribution is described in absolute terms rather than relative. For example: “contributed to designing the study,” “contributed to data analysis,” “contributed to drafting the paper.” A problem with this proposal, Helgesson and Eriksson point out, is that it in fact says very little about absolute contributions. “Contributed to designing the study” can mean both substantial and lightweight contributions.

The article ends by taking a step back. For perhaps we took a step in the wrong direction when we required a more orderly authorship order? The problem about the meaning of the sequence of author names presupposes an individualistic and competitive outlook on science. Today, there are also other tendencies, which may be more worthwhile, such as striving to make science open and socially responsive. Perhaps we should avoid attaching too much importance to authorship order?

Should our focus be on collective contributions to science, with and for society, rather than on individual merit ​​in the competition for employment and funding?

Thus the article ends, with a question calling for more contemplation.

Pär Segerdahl

Helgesson, G. & Eriksson, S. Authorship order. Learned Publishing, 2018, doi: 10.1002/leap1191

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Nurses’ vulnerable position when care and research coincide

September 10, 2018

Pär SegerdahlA new article highlights ethical challenges that nurses face in their profession when more and more clinical trials are conducted on cancer patients.

Nursing alone is stressful. Studies have shown how heavy workload and being pressed for time can cause moral blindness and emotional immunization among nurses. In clinical trials, the situation is even more complicated, due to dual professional roles. The nurses have to accommodate both the values of care and the values of research. Caring for cancer patients coincides with recruiting patients as research participants and coordinating clinical trials on them according to detailed research protocols.

The article by Tove Godskesen et al. describes challenges faced by nurses burdened with this dual professional identity. The most difficult challenges concern cancer patients near the end of life, who no longer respond to the standard therapy. They often hope desperately that research participation will give them access to the next generation of cancer drugs, which may work more efficiently on them. This unrealistic hope creates difficulties for the nurses. They must recruit cancer patients to clinical trials, while the patients often are so terminally ill that they, from a perspective of caring, perhaps rather should be allowed to end their lives in peace and quiet.

An additional complication, next to the heavy workload in nursing and the dual identity as a nurse in the service of research, is that the number of clinical trials increases. There is a political ambition to accelerate the development, to support the Nordic pharmaceutical industry. This means that more and more nurses are engaged to coordinate trials: a task for which they rarely were trained, for which they hardly have time to prepare, and over which they lack power, given their position in the hierarchy of healthcare.

In view of the political ambition to increase the number of clinical trials, there should be a corresponding ambition to support the increasing number of nurses who will have to assume dual professional roles. Godskesen’s study indicates that there is a lack of systematic strategies to handle the situation. Nurses who coordinate trials on patients support each other, to the best of their abilities, over a quick cup of coffee.

Godskesen recommends more strategic training and better support for nurses working with clinical trials. For the nurses’ sake, and not least for the sake of patient safety.

Pär Segerdahl

Tove E. Godskesen, Suzanne Petri, Stefan Eriksson, Arja Halkoaho, Margrete Mangset, Merja Pirinen, Zandra Engelbak Nielsen. 2018. When Nursing Care and Clinical Trials Coincide: A Qualitative Study of the Views of Nordic Oncology and Hematology Nurses on Ethical Work Challenges. Journal of Empirical Research on Human Research Ethics. doi.org/10.1177/1556264618783555

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Where to publish and not to publish in bioethics – the 2018 list

May 2, 2018

Stefan Eriksson, Associate Professor of Research Ethics, Uppsala University

Allegedly, there are over 12.000 so called predatory journals out there. Instead of supporting readers and science, these journals serve their own economic interests first and at best offer dubious merits for scholars. We believe that scholars working in any academic discipline have a professional interest and a responsibility to keep track of these journals. It is our job to warn the young or inexperienced of journals where a publication or editorship could be detrimental to their career and science is not served. We have seen “predatory” publishing take off in a big way and noticed how colleagues start to turn up in the pages of some of these journals. While many have assumed that this phenomenon mainly is a problem for low status universities, there are strong indications that predatory publishing is a part of a major trend towards the industrialization of misconduct and that it affects many top-flight research institutions (see Priyanka Pulla: “In India, elite institutes in shady journals”, Science 354(6319): 1511-1512). This trend, referred to by some as the dark side of publishing, needs to be reversed.

Gert Helgesson, Professor of Medical Ethics, Karolinska InstitutetThus we published this blog post in 2016. This is our second  annual update (the first version can be found here). At first, we relied heavily on the work of Jeffrey Beall, a librarian at the University of Colorado, who run blacklists of “potential, possible, or probable” predatory publishers and journals. His lists have since been removed although they live on in new form (anonymous) at the Stop predatory journals site (SPJ) and they can also be found archived. These lists were not, however, the final say on the matter, as it is impossible for one person to judge reliably actors in every academic discipline. Moreover, since only questionable journals are listed, the good journals must be found elsewhere.

A response of gatekeeping needs to be anchored in each discipline and the scholars who make up that discipline. As a suitable response in bioethics, we have chosen to, first, collect a few authoritative lists of recommended bioethics journals that can be consulted by anyone in bioethics to find good journals to publish with. For our first post, we recommended a list of journals ourselves, which brought on some well-deserved questions and criticism about criteria for inclusion. Unfortunately then, our list ultimately drew attention from other parts of the message that we were more concerned to get across. Besides, there are many other parties making such lists. We therefore have dropped this feature. Instead we have enlarged the collection of good journal lists to the service of our readers. They are all of great use when further exploring the reputable journals available:

It is of prime importance to list the journals that are potentially or possibly predatory or of such a low quality that it might be dishonoring to engage with them. We have listed all 39 of them (up with three from last year, although some are presently not responsive) alphabetically and provided both the homepage URL and links to any professional discussion of these journals that we have found (which most often alerted us to their existence in the first place).

Each of these journals asks scholars for manuscripts from, or claims to publish papers in bioethics or related areas (such as practical philosophy). They have been reviewed by the authors of this blog post as well as by a group of reference scholars that we have asked for advice on the list. Those journals listed have unanimously been agreed are journals that – in light of the criticism put forth and the quality we see – we would not deem acceptable for us to publish in. Typical signs as to why a journal could fall in this category, such as extensive spamming, publishing in almost any subject, or fake data being included on the website etc., are listed here:

We have started to more systematically evaluate the journals against the 25 defining characteristics we outlined in the article linked to above (with the help of science and technology PhD students). The results will be added when they exist.

We would love to hear about your views on this blog post, and be especially grateful for pointers to journals engaging in sloppy or bad publishing practices. The list is not meant as a check-list but as a starting point for any bioethics scholar to ponder for him- or herself where to publish.

Also, anyone thinking that a journal in our list should be given due reconsideration might post their reasons for this as a comment to the blog post or send an email to us. Journals might start out with some sloppy practices but shape up over time and we will be happy to hear about it. You can make an appeal against the inclusion of a journal and we will deal with it promptly and publicly.

Please spread the content of this blog as much as you can and check back for updates (we will do a major update annually and continually add any further information found).

WHERE NOT TO PUBLISH IN BIOETHICS – THE 2018 LIST

UPDATE I:

Journal of International Ethical Theory and Practice (MedCrave)
Criticism 1 │ Criticism 2 │ Criticism 3 │ Criticism 4 │ Criticism 5 │ Criticism 6 │ Criticism 7
Critical remark (May 2018): New journal with no articles or issues yet – but still is in need of so many editors that spam emails are sent. They kindly allow for scientific articles: “The research articles can include the findings and the methodology you used.” MedCrave uses many alternative indexing services. They are listed by SPJ. They also spam the Internet with claims for all criticism to be a hoax or fake news.

UPDATE II:

The following journals are all included in Cabells’ blacklist of “predatory journals”:

  • American Open Ethics Journal (Research and Knowledge Publication)
  • Ethics Today Journal (Franklin Publishing)
  • Universal Open Ethics Journal (Adyan Academic Press)

UPDATE III:

Journal of Research in Philosophy and History (Scholink)
Criticism 1 │
Critical remark (June 2018): Listed on several lists of predatory publishers. They only do “peer review” through their own editorial board, a flowchart states. They claim to check for plagiarism but the first 2018 article abstract run by us through a checker turned out to be self-plagiarized from a book and it looks to have been published many times over. Unfortunately, the next paper checked in the same issue was also published the previous year by another journal listed above…

UPDATE IV:

International Journal of Current Research and Academic Review (Excellent Publishers)
Critical remark (June 2018): Listed by SPJ and Cabells because of misleading claims about credentials, metrics, and too quick review; alternative indexing; publishes in almost any field imaginable; the editor -in-chief is head of the “Excellent Education and Researh Institute” (sic) which does not seem to exist even when spelled right?

UPDATE V:

Annals of Bioethics & Clinical Applications (Medwin Publishers)
Criticism 1 │ Criticism 2
Critical remark: Publisher was on Beall’s list and is on many other lists of these journals. They say that they are “accepting all type of original works that is related to the disciplines of the journal” and indeed the flow chart of manuscript handling does not have a reject route. Indexed by alternative indexes.

End remark:

In light of recent legal action taken against people trying to warn others about dubious publishers and journals – see here and here – we want to stress that this blog post is about where we would like our articles to show up, it is about quality, and as such it is an expression of a professional judgement intended to help authors find good journals with which to publish. Indirectly, this may also help readers to be more discerning about the articles they read. As such it is no different from other rankings that can be found for various products and services everywhere. Our list of where not to publish implies no accusation of deception or fraud but claims to identify journals that experienced bioethicists would usually not find to be of high quality. Those criticisms linked to might be more upfront or confrontational; us linking to them does not imply an endorsement of any objectionable statement made therein. We would also like to point out that individual papers published in these journals might of course nevertheless be perfectly acceptable contributions to the scholarly literature of bioethics.

Stefan Eriksson & Gert Helgesson

Read more about Stefan’s work at CRB here

Essential resources on so-called predatory publishing and open access:

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Rules for authorship must be clarified

April 11, 2018

Pär SegerdahlRecently, I wrote a post on honorary authorships in the academia. When I in that post tried to render the ICMJE criteria for academic authorship, I felt dull since I could not figure out how to express in my own words the fourth criterion:

”Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.”

To count as an author of an academic publication, it is not sufficient to contribute to the research, to drafting or revising the intellectual content of the text, and to approve the final version. You must also satisfy this fourth criterion, which has to do with responsibility for research misconduct.

What does the criterion actually say? After reading an opinion piece by Gert Helgesson and Stefan Eriksson in Learned Publishing, I realize that it was not just my stupidity that caused my difficulties to summarize the fourth criterion. The formulation is ambiguous, which may be due to disagreement among the authors of the authorship criteria!

Helgesson and Eriksson find three possible interpretations of the fourth criterion:

  1. Emphasizing the initial ten words (until the first instance of “work”), the criterion seems to say that all authors are responsible, or should be held responsible, for all parts of the article. If the work was fraudulent in some way, all authors should be held responsible, even if they were unaware of what was going on.
  2. Continuing to read the whole criterion, its meaning changes. The criterion then seems to say that if fraudulence is suspected, then all authors have the responsibility to facilitate the investigation of the suspicions (regardless of what part of the work the suspicions concern).
  3. A third interpretation goes further than the second interpretation. It says that an author should support investigations of fraudulence not only after the article was sent to a journal. An author should initiate such investigations him- or herself already during the research and drafting phase, if he or she suspects fraudulence.

It is impossible to determine which interpretation holds. Helgesson and Eriksson consider the third interpretation most reasonable from a research ethical point of view. If this is the intended interpretation, it should be made linguistically unmistakable in the next revision of the authorship criteria, the opinion piece concludes.

Pär Segerdahl

Helgesson, G. and Eriksson, S. Revise the ICMJE Recommendations regarding authorship responsibility! Learned Publishing 2018. doi: 10.1002/leap.1161

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Risks of discrimination in population-based biobanks

April 4, 2018

Pär SegerdahlEven good intentions can cause harm. Considerately treating certain groups as “vulnerable,” such as pregnant women and children, can cause discrimination against them. If we protect them from participation in clinical research, we know less about how they respond to medical treatments. They are therefore exposed to greater risks when they are patients in need of medical treatment. Thanks for your concern.

Deborah Mascalzoni points out possible discrimination patterns in population-based biobank research. She particularly highlights people with psychiatric conditions, who often are excluded from such studies. However, she also mentions children, who rarely are included in population-based biobanks, as well as people with early forms of dementia or addiction problems.

Mascalzoni thus asks how representative population-based biobanks really are. This is important, as results from such research are increasingly used in the planning of care. We need to see these potential discrimination patterns more clearly, so that people suffering from psychiatric conditions, for example, have similar opportunities to benefit from research as others.

However, the patterns are caused not only by how we think of certain groups as “vulnerable.” Even practical difficulties, to which you may not give much thought, can cause discrimination. It is ethically and legally cumbersome to recruit children as research participants. People suffering from depression may have suicidal thoughts, which requires special efforts. People with early symptoms of dementia may have difficulty understanding complex information, which complicates the process of informed consent.

Some groups are in practice more difficult to recruit to population-based biobanks. Not only our consideration of certain groups as “vulnerable,” then, but also practical obstacles to which we do not pay attention, may cause biased research results, which may lead to poorer care for certain groups. There is therefore reason to ask about representativeness.

Pär Segerdahl

Mascalzoni, D. 2017. Reverse discrimination for psychiatric genetic studies in population-based biobanks. European Neuropsychopharmacology 27: 475-476

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