Welcome to the October issue

By Mary Gabb (mary.gabb@rxcomms.com)

The term “adherence” (or sometimes “compliance”) – the extent to which patients take their treatment as prescribed – has been understood to be a nagging clinical issue, but is now seen as a major cost driver in many therapeutic areas. A recent report from the National Council on Patient Information and Education (NCPIE) in the United States reveals depressing statistics: 49% of those polled had forgotten to take a prescribed medication, 31% had not filled a prescription they were given, 29% had stopped taking a medicine before the supply ran out, and 24% had taken less than the recommended dosage.

A recent report in the Archives of Internal Medicine documents our failed efforts to improve adherence. Only about half of randomised controlled trials designed to improve medication adherence showed any consistent improvement in patient adherence, and less than one third of the studies demonstrated improvement in at least one clinical outcome. Non-adherence has even been referred to as the “other drug problem”.

How does the issue of adherence/compliance affect the field of health economics? The International Society for Pharmacoeconomic Outcomes and Research (ISPOR) has created the ISPOR Medication Compliance and Persistence Special Interest Group to study non-adherence in pharmacoeconomic evaluations. JoAnne LaFleur, Research Assistant Professor at the Pharmacotherapy Outcomes Research Center, University of Utah College of Pharmacy (Salt Lake City, UT, USA) is a member of the ISPOR special interest group on adherence/compliance. She says there has been a surge in the last five years in measuring the cost outcomes of poor adherence. She explains that medication costs are often much less expensive than the surgical or hospitalisation costs if the medications are not taken as directed and the clinical sequelae manifest. LaFleur also says that, in the US, a consistent problem has been that, with a few exceptions, the myriad health insurance plans don’t invest in programmes to improve adherence, in part because their pharmacy budgets are separate from the medical budgets. In fact, management of pharmacy coverage is often outsourced to other companies called pharmacy benefit managers. Thus, each group (pharmacy versus medical benefits) is not considering the ramifications of their decisions on the total healthcare cost, but rather only on their specific budgets.

According to David Nash, MD, MBA, Chairman of the Department of Health Policy at Jefferson Medical College (Philadelphia, PA, USA), who recently reviewed the Archives study, the only techniques that seem to have any impact on improving adherence are “once-a-day dosing and a rigorous reminder system to patients”. For health economists, Dr. Nash sees three main issues regarding adherence and health economics:

• a lack of programmatic progress in improving adherence, as evidenced in the Archives-published study and the NCPIE report
• a lack of understanding of the downstream costs of poor adherence, which are “formidable”
• the effect of co-payment (or “cost sharing”) on adherence.

In our next HOC article on adherence, we will discuss some of the challenges to including adherence in cost outcomes analyses, including effect of co-payment on adherence, as well as the use of accurate models of adherence in cost outcomes analyses – how closely do they reflect real life data?

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"In my 20 or so years in this field, there have obviously been many methodological developments... but I would say that the biggest change in this time has been not so much in the methods but in the use of these studies... the thing that interests me most is the use of pharmacoeconomics studies in decision-making and hopefully they make an important contribution. When I began in pharmacoeconomics, the only people that would read my papers were the University Promotions and Tenure Committee and my Mother, who has always been a great fan of my work! But now, of course, these studies are read by important people making very important decisions. You know, a few years ago people used to ask: Well, why are we doing these studies? Now they are asking me how quickly you can get it done. "
Mike Drummond, Professor of Health Economics, University of York , UK

by Robert Hand (robert.hand@rxcomms.com)

For a variety of reasons, pharmaceutical manufacturers often do not conduct head-to-head studies of their drugs versus the competition. On the other hand, head-to-head studies are the ultimate choice for people who have to make comparative assessments of drugs.

In the absence of head-to-head studies, decision makers generally have to make do by trying to compare competing therapies by looking at studies that have the most similarities (patient population, disease characteristics, treatment plan, etc). An important consideration in comparing studies is study design, and in particular, the methods used for analysis of the primary end points.

A common method for analysis is the last observation carried forward (LOCF) method. For subjects who for whatever reason drop out of a clinical study, the last-measured value for a variable such as response to treatment is carried forward and assumed to be valid for the last scheduled measurement in the study.

An alternative is the non-responder imputation (NRI) method. In this method, which is used for dichotomous (“yes or no”) or categorical variables, if a subject drops out of a study, that subject is assumed to be a non-responder, regardless of whether or not the subject was responding to treatment at the time of dropout.

Why is the method of analysis important? It can significantly affect the apparent result of a study. In the LOCF method, for example, the last observation is often the best observed for subjects who drop out because they cannot tolerate the therapy. This biases the result in favour of the active treatment. In contrast, NRI is a conservative method that avoids this bias. NRI may, in fact, underestimate the efficacy of a therapy, for example by categorising as a non-responder a subject who may have dropped out simply because he moved or couldn’t make scheduled study visits. Because NRI is conservative, it is gaining respect as an analytical method. In fact, according to Okamoto et al*, the US Food and Drug Administration sees LOCF as no longer acceptable for some analyses, favouring conservative methods of imputing missing values.

NRI is, in fact, one of several methods of imputation, including worst observation carried forward (WOCF), group mean imputation (GMI), placebo mean imputation (PMI), and imputation based on the reason for discontinuation (IDUR). Furthermore, conservative methods and LOCF can be used appropriately in the same study. (NRI is not appropriate for continuous variables.)
The point for those who evaluate drugs and therapies is this: when comparing studies, know which analytical methods are being used, and understand how the choice of analytical method can affect how study results look.

*Okamoto A, Wang J, Mohanty S. Rescue behavior and imputation strategies in analgesic studies (PowerPoint presentation). Accessed at http://bass.georgiasouthern.edu/PDFs/BASS%202006%20 Julia%20Akiko.pdf, 01 October 2007.

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How to write a good sentence – length and rhythm

by Clare Gurton (clare.gurton@rxcomms.com)

A sentence should not only make sense but should also be capable of standing alone as a complete unit; a good sentence will also have shape and form.

Sentence length is important in any piece of writing. While there are no set rules for this, shorter sentences are better. If the length of an average sentence is 15 to 20 words, then it’s best to vary length around this norm rather than sticking to a single pattern which can become monotonous.

If you want to introduce an element of pace or urgency to your work then very short sentences are ideal. But be careful not to overdo this staccato form: a succession of short statements can become just as tedious as long sentences.

Longer sentences can be useful but must retain logic and clarity; the great danger with longer sentences is that the message becomes blurred and readers lose touch with the first part of the sentence by the time they have reached the last part. This last, for example, was 45 words long, but I hope that the message retained clarity. When you edit your writing, work on your sentences; some might need shortening and others lengthening.

Another aspect of sentence structure is rhythm. This is not easy to teach; it is more instinctive and comes from experience, both of writing and reading. Good writing has a certain rhythm which, unlike poetry, is not regular or repeated; more a subtle satisfying sequence of sentence flow. Such flow makes it easier to get the sense of the piece at the same time as enjoying the reading.

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By David Woods (david.woods@rxcomms.com)

Health clinics based in retail outlets, particularly drug stores, are changing the way primary care is delivered. Their proponents cite access, convenience, and price transparency as the major reasons for their popularity and growth. Further fueling this concept is the growing shortage of primary care doctors.

Staffed mainly by nurse practitioners, the clinics offer quick services for routine health conditions such as colds and sore throats that formerly would have taken patients to the office of a family physician or general internist.

The expansion of these clinics is nothing short of phenomenal. Their umbrella trade group, aptly titled the Convenient Care Association, estimates that there will be more than 700 of them by the end of this year, and some 2000 by the end of next year.

Initial concerns by medical associations that the clinics would be unregulated and provide mainly
one-shot care other than continuity are largely dissipating. For example, Minneapolis-based MinuteClinic – a subsidiary of CVS Caremark Corporation and the largest provider of retail-based healthcare in the US – now has full accreditation from the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). Its president, Michael Howe (pictured left), a former executive with Procter & Gamble, told HOC: “Our services complement primary care providers and our nurse practitioners make it a point to stress the importance of a regular medical exam with every patient they see.” He adds that “waiting times, compared with a doctor’s office, typically are about 15 minutes... and the average cost is about $60.”

The American Academy of Family Physicians (AAFP), rather than opposing the concept, has issued a set of standards for in-store clinics... and a former AAFP president serves on the company’s Clinical Quality Advisory Council.

A by-product of the clinics is that they have an impact on employee productivity because of the time saved in comparison with time spent in doctors’ waiting rooms.

In the United Kingdom, plans are in motion to formalise minor ailment clinics where pharmacists and nurse prescribers can serve to direct patients away from busy doctors’ offices. The major UK pharmacist chain, Boots, is establishing walk-in clinics in concert with major supermarkets. However, such clinics have been slow to take off because they are limited by the National Health Service Primary Care Trusts’ budgets, since both doctors and pharmacists operating in these clinics will be seeking reimbursement for their prescribing.

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“Medicine has become the prisoner of its success. Having conquered many grave diseases and provided relief from suffering, its mandate has become muddled. What are its aims? Where is it to stop? Is its prime duty to keep people alive as long as possible, willy-nilly, whatever the circumstances? Is its charge to make people lead healthy lives? Or is it but a service industry, on tap to fulfill whatever fantasies its clients may frame for their bodies?”
Roy Porter (1946–2002) – British medical historian

By David Woods (david.woods@rxcomms.com)

Entusiasmo. That’s a word that describes, in his native Italian, what Vittorio Maio brings to his work in health policy and outcomes research. “What makes me really happy,” he says, “is being able to see research theory translate into actual practice in the real world.”

Vittorio graduated from the University of Perugia and moved to the United States in 1999; there, he immediately joined Dr. David Nash’s Department of Health Policy at Thomas Jefferson Medical College, where he is a research assistant professor and director of the Fellowship programme in outcomes research.

But he has not lost touch with his professional and cultural roots. A few hours after our interview for this article, he was winging his way back to Italy – a trip he makes four or five times a year. In Bologna, he conducts population-based outcomes research with a unique healthcare database. The studies embrace differences in the use of health care services between men and women, the elderly, and children; they look at approaches to, say, cardiac care and how general practitioners might be persuaded to change their approaches to treatment and prescribing. They are even touching gently upon the idea of pay-for-performance among physicians.

Vittorio brings this international perspective to his professorial role at Jefferson. He finds that his students are particularly receptive to this... and he is not afraid of editorialising on the subject of American healthcare, which he describes as the most regressive system in the world. “We all pay the same,” he says. “People should pay according to their resources.”

In general, Vittorio's particular research enthusiasm has to do with the elderly, with trying to change physician behaviour, and with pay-for-performance – linking quality to incentives. Beyond that, he says, non-adherence to drug regimens “is a huge interest.”

Asked about HOC, he is equally upbeat: “What you're doing,” he says, “is an important way to connect health economists, researchers and decision-makers. It's concrete, an easy read, and credible.”

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