- by Katrin Rut Sigurdardottir
This is a fundamental question when reading a scientific paper. Unfortunately, all too often the description of the patient population is insufficient in trials in end-of-life and palliative care. Many of us have read interesting papers from studies with impressive results, but due to the lack of an adequate description of the sample, the results have been useless to us.
Patients entering our trials, as well as health care professionals putting much effort into data collections, deserve that study results can be generalized to groups and settings beyond those included in the trial. One of the main reasons for many palliative care patients to participate in clinical studies, is that the results can be of help to others.
The need to standardize reporting has been recognized for many years. The PRC in collaboration with the EAPC-RN and the project PRISMA started in 2010 a process to develop and reach consensus on a basic set of variables to describe a palliative care cancer population. In a five step Delphi exercise, 64 experts from 30 countries reached consensus on 31 variables to be included in the EAPC Basic Dataset. The paper describing the work was recently published online in Palliative Medicine:
Katrin R Sigurdardottir, Stein Kaasa, Jan H Rosland, Claudia Bausewein, Lukas Radbruch, Dagny F Haugen, on behalf of PRISMA: The European Association for Palliative Care basic dataset to describe a palliative care cancer population: Results from an international Delphi process.
The EAPC basic dataset of patient characteristics and medical variables provides a unique platform for standardizing research reporting, and a common framework for researchers, clinicians, and other palliative care stakeholders. The EAPC basic dataset is now available as PDF files on the PRC website, and will soon also be available on the EAPC homepage.
I strongly encourage researchers and clinicians to start using the dataset. We owe that to patients participating in our trials.
Ever struggled with writing your research article? Based on his 25 years of experience in writing articles PRC director Stein Kaasa gives you the recipe for writing a nice and tight article in about 35 minutes (only one presupposition: You know what you want to write about).
How do you get started?
- You start by writing the overall aim of the article/project in 1-2 sentences – crispy clear!
- When you have written it – understand it! If you do not get the story, you cannot tell anyone else about it.
- Keep in mind that the overall aim should lead to an overall conclusion.
- Then, write down your research questions. Research questions are sentences with a question mark at the end.
- Research questions should put the article into a context – these are the questions you will be answering in your discussion.
Move on to the Introduction
- Do you know the two main aims of the introduction? Here they are:
- Introduce the reader into the level of evidence in the field, based on existing literature. This should show the reader why your study makes sense in the field. Give the reader the most important references. You don’t have to include 70 references, 20 might be a sufficient number (especially since you need to refer to them once more; in the discussion).
- Present the overall aim and research questions (which you have already written…)
- The reader should get an appropriate impression of what your article is about by reading the first (main information on what the article is about) and last (aims and RQ’s) paragraph of the introduction.
- For the paragraphs in-between, write down in keywords your 3-5 main messages/themes. Then fill in the details and structure the text according to the overall rule: One idea – one message – one paragraph.
Materials and methods
- The easy one.
- Simply write down what you have done, how you have done it – and with whom.
- Also quite easy.
- First, make the tables. You might plan which tables to make long before the analysis have even started. All the results might be put into tables. Make as many as you like and save all of them in case you need them later, e.g. for a conference speech.
- Table 1: Most often patient characteristics
- Table 2: Presentation of main outcomes (might eventually be converted into a figure)
- Table 3-10: More outcomes
- Give the tables functional headings and make sure they are understandable independent of the text
- Secondly, consider if any of the findings could be presented in a figure – such as a graph or a bar chart
- Finally, write the results narratively. Paragraph by paragraph, guide the reader through the tables. No nitty-gritty details, no interpretations, and no emotions. Ice cold!
And then, the discussion
- Unfortunately or fortunately, the writing recipe is not sharply defined for the discussion. However, we offer some strategic approaches:
- Decide upon the 4-5 main points for discussion and write them down as keywords. Fill in according to the rule presented above.
- The first paragraph might be a summary of the main findings; a teaser.
- Discuss the main findings. This means: Answer your research questions. For your sake, I hope you have formulated them precisely.
- You probably had at least two research questions. You get the drill by now – discuss one of them at a time, one paragraph for each.
- Remember to go back to the introduction in order to relate your findings to the literature you presented there (you got an obvious hint about this above). Reflect on this for a minute.
- Present the study’s limitations, i.e. weaknesses related to material and methods.
- We are getting close to the final now, and here are two parts of the discussion that might demand some extra effort:
- Put the results into a larger context. This means to reflect upon your overall aim (which you, thank goodness, have written crispy clear upfront)
- Show how the reader could apply your findings in the clinic or in further research.
- The conclusion – phew! (Actually, you might want to write this directly after writing your aim – and what a relief – then you have finished your article before this last bullet point.). If the conclusion does not correspond with the introduction – start over.
Writing informed consent forms for patients who are asked to take part in clinical trials could be really challenging. The writer (the investigator) on the one hand has to fulfill the content requirements of such forms from ethical guidelines and ethics review board, and on the other hand he has to present the content in a way that all the eligible participants in his study can understand. Here are a few suggestions for what to bear in mind when explaining the trial to your patients:
1. Let research be the main topic, not treatment. Of course, treatment procedures are necessary to explain to the reader, but the treatment should be clearly presented as part of a trial.
2. Clarify the consent form is not merely information about a study, but that the information is conveyed because the reader is supposed to use it as a decision support in the consent process. This could be stated for instance by use of metainformation such as “You are asked to take part in a medical study. The information you get in this form and from your physician is supposed to help you decide whether or not you want to take part in the study”.
3. Clarify the relationship between the reader and the writer. It is a possible source of confusion that the actors in the consent process (and the whole trial situation) have dual roles: The doctor is also an investigator, and the patient is also a trial participant. Being a trial participant have other implications than being “only” a patient.
4. Orient the information to the target reader, i.e. the possible trial participant (not a regular patient, not the ethics review board). Explain the implications of consenting and of refusing.
5. Explain expert terms; do not avoid them. Consent form most often have to consist of information about complex medical research. Expert terms might be necessary in order to make the information sufficiently precise. Use them, and explain them in lay terms.
In September 2011, the United Nations hosted its second only Heads of State summit on health. The topic was non-communicable diseases. The four major disease streams were cardiovascular disease, respiratory disease, cancer and diabetes.
Each of these diseases has a group of people who will experience progressive disease with an increasing symptom burden. This burden will be seen in resource poor countries in increasing numbers in the decades ahead.
The Union for International Cancer Control (UICC) was active in advocating for good palliative care as part of the key planning that needs to be done. There was a small committee with representatives from around the globe who put together key fact sheets. Sadly the final communiqué of the summit only mentioned palliative once, but the resources developed are now being made widely available. They can be downloaded here and here, and focus on the practical things that can be done at a policy level to improve palliative care at a jurisdictional level.
Posted by David Currow, Professor, Flinders University, Australia.
Another eventful year for ATOME
After having achieved several important milestones last year, 2012 will be another eventful year for the Access To Opioid Medication in Europe (ATOME) project.
The overall goal of this project is to undertake applied research into the reasons why opioid medicines for moderate to severe pain and for the treatment of opioid dependence are often not available where needed and not used adequately in twelve European countries.
2011 – analysis, foundation, preparation
Last autumn, two six-country workshops were successfully realised in Bucharest (Romania) with delegations from all twelve target countries and a guest delegation from the Ukraine participating and developing national action plans for improving access to opioid medications. By the end of 2011, the “quick scan” of legislation had been performed with the aim to detect aspects that are a potential barrier to the access and availability of opioids in the respective country.
2012 – dissemination, intensification, implementation
This year, a series of national 1-day conferences will be started aiming at sensitisation of key stakeholders towards opioid availability in their country. The results of the quick scan of legislation will be followed up by a more in-depth analysis of the legislation in the target countries.
For more information, visit the ATOME session at the next EAPC World Research Congress in Trondheim (Thursday 7th June 2012, 18:00 – 19:00) and the ATOME website.
Posted by Saskia Jünger, Dr. rer. medic., University Hospital Bonn, Germany.
Mantovani described inflammation as the 7th hallmark of cancer, citing its importance both for tumour development but also maintenance of the cancer state (Nature 2008). What is becoming clear is that inflammation has implications for symptom management as well.
Cancer cachexia is well recognised to have systemic inflammation at its core and possible therapies to treat this underlying inflammation are currently being investigated (preMENAC Study-PRC). Pain is also related to inflammation. This has been described as early as the 1st Century AD by the roman encyclopaedist Celcus. Recently the specific link between pain and inflammation in cancer has been described (Laird et al, Pain 2011).
In addition to pain and cachexia, inflammation has been suggested as a cause of some symptom clusters (pain, depression, fatigue) in cancer. This cluster is similar to animal models of cytokine induced sickness behaviour and further examination of this in human studies would be of interest.
In treating cancer symptoms, we treat from the front; once symptoms have developed symptoms are attenuated, where possible, with medication. As our understanding of inflammation in symptom development increases, inflammation may provide a target in treating cancer symptoms at their genesis.
Such an approach would be of interest and potentially therapeutic value. Studies fully exploiting the pro-inflammatory response as a target in the treatment of cancer symptoms are eagerly awaited.
Posted by Barry Laird, MD, University of Edinburgh, UK and NTNU, Norway.
Pain is the most prevalent and feared symptom of all cancer patients, and studies show that a lot of patients are not sufficiently treated. This makes research on use of opioid analgesics crucial.
This week the European Association for Palliative Care (EAPC) guidelines for use of opioid analgesics in treatment of cancer pain, authored by PRC researchers, were published in Lancet Oncology. The guidelines are updates of previous recommendations, giving health care providers state-of-the-art evidence-based ways to treat cancer pain.
So how did these guidelines come to be?
1. Previous guidelines
The last version of the EAPC guidelines were reviewed and compared with other available guidelines, and consensus recommendations were created by an international expert panel. The content was divided into 22 topics.
2. Systematic reviews
Each topic was assigned to collaborators who developed systematic literature reviews, all using the same methodology when performing the reviews.
3. Writing recommendations
A writing committee combined the evidence derived from the reviews with the evaluations of the expert panel, and the results where endorsed by the EAPC Board of Directors. The outcome was 16 recommendations for use of opioid analgesics when treating cancer pain.
Posted by Ragnhild Green Helgås.