This month we continue our internet series by taking a look at email security. Email has become an essential part of business and domestic life, but is all too easily open to abuse. Mary Gabb offers some tips on how to be sure your email communications remain confidential. Ruth Whittington follows this with the last part in her series on observational studies, discussing how to interpret the results.
Drug labelling is scrutinised by your editor, who also interviewed Diana Brixner, the new president of ISPOR. She explained that the society’s agenda for the future is to bridge the gap separating academics and outcomes researchers from the people who actually make economic decisions. Finally we round off our summer issue of HOC with some advice to take time out to refresh your senses – to see, hear and smell the world around you.
David Woods – HOC editor
Big Brother may be reading your emails
By Mary Gabb (mary.gabb@rxcomms.com)
Billions of emails are sent each day round the world. What most people don’t realise, however, is that email is like a postcard; it can be read by anyone who knows how to access email as it travels from computer to computer across the internet, until it reaches its destination. Thus, the sender must assume that his or her emails are being read by others, just like a postcard.
If you need to send sensitive information, such as a social security number (in the USA, or its equivalent in other countries), sensitive company information, or patient records, you should not include it in the body of the email or as an attachment. There are several alternative solutions:
- Encryption. It is relatively safe to send a password-protected, encrypted file via email. However, the filename should not give any information about the contents (eg, Clinical_Trial_Results.doc). If the file is intercepted, the thief most likely would not be able to unpack it without the password, provided the password is strong (more about that below), but you have just informed or confirmed for the thief that the information of interest is right there in his hands, which would make him work all the harder to crack the password. Emails themselves can also be encrypted.
- FTP (File Transfer Protocol) sites. In general, one cannot assume that an FTP site is secure. Even if the FTP site is secure, transfer to the site may not be; an unencrypted transfer can be intercepted. However, most FTP programs allow the user to perform encrypted transfer. Also, even if the FTP site is insecure, one can still transfer a password-protected, encrypted file.
- Protect your liability. You most likely will have seen language in some emails, along the lines of, ‘This email is intended only for the individual to whom it is addressed. It may contain privileged and confidential information...’, asking readers to disregard the message if they are not the intended recipients, and that the sender is not responsible for any damage caused by sending the email. Check with your institution’s legal department on appropriate language for your emails, which may vary by department.
Use a strong password
Passwords are increasingly susceptible to cracking, but if carefully crafted, they can make it much harder to decode. Microsoft recommends using a password that has eight letters minimum (preferably 14), mixing upper and lower case letters, including at least one number and also, preferably, a symbol. People often use variations on their own name, a pet’s name, or their children’s name(s). However, the password should not contain a word that can be found in the dictionary. Examples of weak and strong passwords are:
- Weak passwords: Fluffy, MyName
- Strong passwords: FluFfy!115, Hamp1on#723
Passwords are most often stolen through ‘phishing’ (ie, an email containing links to fake websites that appear to be legitimate websites, for the purposes of harvesting passwords) and ‘social engineering’ (a collection of techniques used to manipulate people into performing actions or divulging confidential information). In fact, a password is more likely to be phished than cracked.
Patient confidentiality
It’s important to maintain confidentiality of patient records, even if those records are pseudonymised or anonymised for health economics research. Both the American Medical Association and the UK General Medical Council have stated that patient records transmitted electronically fall under the ‘doctor-patient confidentiality’ agreement, and so need to be protected.
If all else fails, remember to close/lock your computer screen when you leave your office!
I know nothing more pleasant, or more instructive than to compare experience with expectation,
or to register from time to time the difference between idea and reality. It is by this kind of observation
that we grow daily less liable to be disappointed.
Samuel Johnson (author, linguist, lexicographer, 1709–1784). Letter to Bennet Langton.
Observational studies: answering real-life questions about healthcare practice
By Ruth Whittington (ruth.whittington@rxcomms.com)
Part 4 – Interpreting the results of observational studies
In the last of our series on observational studies, this article addresses some of the issues involved in interpreting the results of such studies.
When interpreting or reviewing the results of any study or trial, there are important questions that should be kept in mind to ensure objective and balanced assessment of both the results and the possible implications for future healthcare.
Some of these questions apply to the conduct and design of the trial, for example:
- was the study conducted in an ethical manner?
- was the design of the study appropriate to answer the research questions that were asked?
- were the research questions clinically relevant and scientifically valuable?
However, bias, confounding factors, heterogeneity of the patient groups, and statistical power can all affect the interpretation and implication of the results. These potential influences need to be examined closely.
Bias
Bias occurs when preconceptions lead to incorrect conclusions about the effects of treatment. It is important to avoid bias in health research as it distorts outcomes – it could even result in an unsafe or inefficient treatment being licensed for use, or useful treatments being overlooked. Bias is avoided in RCTs by the process of randomisation, and in observational studies statistical analyses can minimise its effects.
Confounding factors
‘Confounding’ is when factors other than the treatment in question could influence the outcome. This can lead to erroneous conclusions, particularly in an observational study. For instance, patients with the worst prognosis may be systematically allocated to a particular treatment. It is possible to control for those confounding factors that are known to affect treatment outcomes, but it may not be possible to control for all confounding factors in an observational study.
Heterogeneity
Because enrolment in an observational study has few restrictions, the study patient population is usually more heterogeneous than that for an RCT. Statistical tests of heterogeneity are used to assess whether the observed variability in results is greater than that expected to occur by chance.
Statistical power
The statistical power is the ability of a study to demonstrate an association or causal relationship. If the statistical power of a study is low, the results will be questionable. By convention, 80% is an acceptable level of power. As with the design of an RCT, researchers must estimate the parameters needed to detect a difference between treatments in an observational study – for example, the numbers of patients and the length of follow-up.
A checklist can be helpful to determine whether these and other issues have been adequately addressed in the study report, and thus give a degree of confidence about the results. Some useful questions to consider are:
- has the measurement of important confounding factors been described, so that the reader can judge how they can be controlled?
- have all the subjects been accounted for in the study follow-up?
- has any issue of possible bias been addressed?
- is the statistical power of the study adequate to establish a difference between treatment groups?
- has ‘clinical significance’ been discussed so that it can be differentiated from ‘statistical significance’?
- do any measures of association have confidence intervals reported?
- has the issue of multiple comparisons been addressed?
- have the study results been placed in the context of existing findings, and any reasons for differences been discussed?
It is also vital, once you have reached the manuscript stage, to put the study into context alongside the evidence generated by other sources, including RCTs. Explaining any differences in findings is a crucial part of having the study results accepted as a significant contribution to the whole. We wish you luck in conducting these studies – we consider them an essential part of the evidence base for a therapy, and encourage you to consider them in your research planning.
If you want examples of some excellent observational studies in the industry, Lilly is a major contributor to this type of research. SOHO, ADORE, EDOS and EMBLEM are some of the acronyms of their studies. Google will pick these up if you add the word ‘study’ to the search term.
Simplifying drug labels
By David Woods (david.woods@rxcomms.com)
The Institute of Medicine, which made headlines some years ago when it estimated that medical mistakes kill as many as 98,000 patients a year, followed up more recently with a report on the major cause – medication errors.
The Institute believes that one way to prevent such errors is through computerised prescribing systems; another is to present drug labels in clear English. The Institute wants hospitals to computerise their prescribing systems by next year and to start using them by 2010. It also wants the drug industry and the FDA to avoid the confusion created by look-alike and sound-alike drug names – and to simplify labels and packages.
In a study published in the Annals of Internal Medicine, Terry C. Davis and colleagues asked patients at three primary care clinics to demonstrate their understanding of five common drug labels. Almost half of the patients misunderstood at least one of the five labels. For example, the requirement that ‘medication should be taken with plenty of water’ raises the question about what exactly ‘plenty’ means. The exhortation to ‘avoid prolonged exposure or excessive exposure to direct and/or artificial sunlight while taking this medication’ was understood by fewer than 40% of patients with an 8th or 9th grade education in the Davis study, and by a mere 4% of those with a 6th grade level.
Patients also confused tablespoons with teaspoons and were less likely to understand multiple instructions such as ‘take one tablet by mouth twice daily for seven days.’
It is surely in the best interests of both the patient and the pharmaceutical industry that drug labels be worded in language that can be understood by anyone. Clear, simple, unambiguous, helpful … and, above all, not hazardous to health.
HOC people – Diana Brixner
By David Woods (david.woods@rxcomms.com)
Newly-installed ISPOR president Diana Brixner, RPh, PhD, has put together a challenging agenda for the society during her term of office.
The central point of that agenda, she tells HOC, is to bridge the gap separating academics and outcomes researchers from the people who actually make economic decisions. Achieving that, she says, involves giving decision-makers a more active role on ISPOR committees in order to influence our studies
Dr. Brixner, a medicinal chemist and chair of the Department of Pharmacotherapy at the University of Utah, plans to increase even further ISPOR’s international presence and to strengthen the Society's voice in global health policy issues. “We need to reach outward,” she says... expanding our presence into Eastern Europe, Latin America, Singapore, South Africa, and Latin America. ISPOR’s North America meeting next year will be held in Toronto, while the European version is scheduled for Dublin this year and Athens next year. In fact, Dr. Brixner is headed to Athens shortly to work with the Greeks in jumpstarting an ISPOR chapter in that country and to lay the foundation for the November 2008 European conference.
The new president points to the fact that ISPOR has grown from 35 founders in one country in 1995, to more than 3300 members in 80 countries today. “We are viewed as the predominant society focused on patient outcomes, including economic, clinical and patient reported outcomes,” she says, adding that the organisation’s Good Research Practice Reports are used as guidance for research throughout the world; moreover, the ISPOR Medical Device and Diagnostic Outcomes Research book is nearing publication. It epitomises another strong agenda item for the organisation – the need to continue to broaden the scope of its membership by embracing all aspects of health technology, including devices, orphan drugs, biologics, genomics, and diagnostics.
Abstract submission deadlines
Please note that dates were correct at time of sending this email; HOC cannot be responsible for any amendments.
Submit |
Meeting |
Abbrev. |
Therapeutic |
Meeting date |
|---|---|---|---|---|
| 3 Sep 07 | Annual Meeting of European Society for Sexual Medicine Lisbon, Portugal www.essm.org |
ESSM | Men’s health | 25–28 Nov 07 |
| 4 Sep 07 | Annual Meeting of American Academy of Allergy, Asthma and |
AAAAI | Anti-infectives | 14–18 Mar 08 |
| 6 Sep 07 | Annual Meeting of American Psychiatric Association Washington, DC, USA www.psych.org |
APA | Central nervous system |
3–8 May 08 |
| 14 Sep 07 | Drug Information Association Annual Workshop on Pharmaceutical Outcomes Research, Boston, MA, USA www.diahome.org |
DIA | General | 22–26 Jun 08 |
| 15 Sep 07 | American Academy of Nurse Practitioners Washington, DC, USA www.aanp.org |
AANP | Nursing | 26–30 Jun 08 |
| 17 Sep 07 | International Nursing Research Conference Liverpool, UK www.man.ac.uk/rcn/research2008 |
INRC | Nursing | 8–11 Apr 08 |
| 17 Sep 07 | Annual Conference of the American Academy of Physician Assistants, San Antonio, TX, USA www.aapa.org |
AAPA | General | 31 May– 5 Jun 08 |
| 30 Sep 07 | Annual Conference of the National Institute for Health and Clinical Excellence, Manchester, UK www.nice.org.uk |
NICE | General | 5–6 Dec 07 |
Reviewer feedback
One of these safeguards is our reviewer feedback system. Everything we write is not only read and commented on at every major stage by an expert writer new to the project (only our best competitors match us on this), but in addition we require all our reviews to undergo a predefined series of checks. Amongst the 72 questions our reviewers must answer are… From the Content section From the Methods section From the Client / Author queries section We have to do this – we need to sleep! Rx website info@rxcomms.com
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Great communication is our goal, but accuracy is our watchword. In this industry the ease at which errors can creep in is truly terrifying. To allow our staff to sleep at night we employ overlapping tiers of safeguards to check and double-check the accuracy of our output.
Why not take a ‘sensory break?’
by Clare Gurton (clare.gurton@rxcomms.com)
During a coffee-break at a recent medical conference, I went outside and almost immediately became aware of the familiar sounds of swifts high above. As I looked up, a whole group of them flew past in an amazing display of aerial acrobatics. The experience served as a timely reminder that there is life beyond medical conferences.
Yet glancing back at the other delegates around me I realised that I was the only person to have looked up and witnessed the swifts’ fly-past. I’m sure that many of my colleagues were having important and stimulating conversations and I’m fully aware of the importance of networking at such meetings. But I also believe that it is too easy to become too intense, and immersed in work.
Conscious pausing from the immediate work environment can bring enormous benefits; it can let thoughts settle and refresh a tired spirit. It is really worthwhile to build breathing space into your schedule. If necessary, wake up earlier so you can lie in bed longer and collect your thoughts and luxuriate in (possibly) the only peaceful time of the day ahead. In addition, try to pause for a moment (it need only be minutes) each day and awaken your sensory awareness.
- Look at the sky, the trees or buildings around you.
- Listen to the sounds above the clamour of the office or the traffic and see if you can hear birdsong.
- Smell the air – there are often small yet exquisite smells that can stir memories, colour emotions and transform moods.
- Taste your food and enjoy the pleasure of eating.
More in our series on the power of the internet, sorting out the varying standards for pharmacoeconomic guidelines, and the importance of understanding study design when comparing drug studies.
HOC is your publication, so please send us your requests or comments. Just email to andy.brierley@rxcomms.com.
If you have missed any of our earlier issues, email andy.brierley@ rxcomms.com for a copy. See the HOC page on the Rx website for a full list of previous articles.
HOC is available for print in pdf format – free
You can of course print this e-newsletter straight from your inbox (for best results select landscape in your printer’s print set up), but HOC is also available as a professional 4-page A4 newsletter in pdf format for you to print and keep for reference. Simply email andy.brierley@rxcomms.com for past copies. If you would like to be sent a pdf version each month let us know and we’ll send one as soon as it is available.
Healthcare Outcomes Communicator is designed to help you explain and enhance your role and value as healthcare economists and outcomes researchers. But we need input from you – the professionals working "in the trenches". So we encourage you to give us your feedback about how we're doing – to communicate with us so that we can better communicate with you.
Yours sincerely
David Woods and the Rx Communications team
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