In the US, two leading health researchers, Steven Woloshin and Lisa Schwartz, recently called for fact boxes to be included with medications and pharmaceutical ads to provide a standardised, easy-to-read format that would help people weigh up potential benefits and harms (see an example at the bottom of this post).
They wrote in The New York Times:
After 33 years of deliberation, last month the Food and Drug Administration announced rules requiring manufacturers to clarify how well sunscreens protect against UVB and UVA radiation — in other words, how well they actually work. Next, the agency could help consumers understand something far more important: how well a prescription drug actually works.
Meanwhile, Australian researchers, as mentioned in a recent Croakey report on the Australasian Cochrane symposium, have been working to improve the quality of patient information leaflets. Below they provide more details about a framework they’ve developed for evaluating such leaflets.
A framework for improving information for patients
Rosemary Clerehan and Rachelle Buchbinder write:
There is a wealth of written information that the general public and patients can access about medical conditions and their prevention and treatment.
For example, doctors often provide patients with written information leaflets about the medications that are prescribed. These are often of variable quality and content and may or may not address the needs of the patient.
Commonly, an assessment of the quality of information leaflets has involved measuring their ‘readability’ by looking at variables such as the average sentence length in the leaflet and/or the average number of words with 3 syllables.
This is said to provide an estimate of the reading grade level required to understand the text however it is well known among linguists that other factors, such as the overall organisation of the leaflet, the actual vocabulary that is used, the prior knowledge of the reader and the role relationships between the writer and the reader are likely to be more important.
This is why we have developed and validated a new tool, the Evaluative Linguistic Framework (or ELF), for evaluating and improving the quality of written information for patients. Initially developed for assessing the quality of medication information leaflets for rheumatoid arthritis drugs, this tool is likely to be useful for assessing other types of medication leaflets and be generalisable to other types of written information.
Aspects that are considered to be important include the presence of a recognisable generic structure (just like a recipe has a recognisable generic structure consisting of elements such as the ingredients, number of people it will feed, an ordered description of how to proceed etc).
For medication leaflets, these include sections on what the drug is and what it does, instructions for how to take the drug and information regarding monitoring, an outline of the benefits and possible side effects, information about when the drug should not be used, constraints on patient behaviour, storage instructions and when and how to contact a doctor if required.
In the leaflets that the authors have assessed to date, a standard approach by the writers appeared to be lacking, including little agreement about either the purpose or extent of information that should be provided.
It was also not always clear what the reader should do with the information presented (e.g. ‘special care must be taken’ provides vague instruction at best); and the responsibilities of author and reader were not always clearly defined (e.g. if side effects occur the treatment will be stopped’ fails to indicate whose responsibility it is to stop the treatment).
In addition, none of the documents specified their sources of information or gave a sense as to the quality and/or strength of the evidence, and none identified any contentious issues, even though the factual information varied widely.
Of particular important to patients, is that the leaflets not be written using verbose or highly technical jargon; that leaflets that include subheadings in the form of questions ensure that the answer follows; and that the tone of the leaflet by positive and not patronising. They also want to know what the whether the information is up to date.
In feedback provided by patients with rheumatoid arthritis, their assessments of what constituted a ‘good’ leaflet aligned with elements of the linguistic framework. They consistently preferred leaflets written with some knowledge of the ELF.
Future work could utilise the framework to evaluate and/or develop written information on other treatments and procedures, or on healthcare information more widely.
• Rachelle Buchbinder is a rheumatologist and Rosemary Clerehan is an applied linguist at Monash University.
Clerehan R, Buchbinder R, Moodie J. A linguistic framework for assessing the quality of written patient information: its use in assessing methotrexate information for rheumatoid arthritis. Health Educ Res 2005; 20(3):334-44.
http://her.oxfordjournals.org/content/20/3/334.full (accessed July 10, 2011)
Clerehan R, Buchbinder R. Towards a more valid account of functional text quality: the case of the patient information leaflet. Text & Talk 2006; 26(1):37-66.
Hirsh D, Clerehan R, Staples M, Osborne R, Buchbinder R. Patient assessment of medication information leaflets and validation of the Evaluative Linguistic Framework (ELF). Pat Educ Counsel 2009;77:248-54.
http://www.pec-journal.com/article/S0738-3991(09)00133-5/abstract (accessed July 10, 2011)
NOTE: This paper was awarded the inaugural Helen Moran Award in 2010 by Arthritis Victoria (awarded for the best Victorian research paper likely to have the most impact for people with arthritis)
Clerehan R, Hirsh D, Buchbinder R. Medication information leaflets for patients: the further validation of an analytic linguistic framework. Communication & Medicine 2009; 6(2): 117-27.
For more reading about the medicines fact boxes proposed in the US, see Gary Schwitzer’s Health News Review article (from where this illustration comes)