Welcome to the April issue

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by Mary Gabb (mgabb@rxcomms.com)

Writing a manuscript can be daunting, even for a seasoned researcher. How does one synthesise a coherent publication out of the mountain of accumulated data? The most traditional approach is to start with the IMRaD principle: Introduction, Methods, Results, and Discussion. But how to summarise all of those results? This is a common challenge, but it can be overcome with a straightforward approach and by being mindful of two key principles:

• Always keep in mind the original research question. All of the data you choose should be able to answer the original research question. Data that do not answer the primary question should not be included (although if secondary endpoints or hypotheses were tested, relevant data for those questions can be included, depending on your word count limits).
• Be as clear and transparent as possible. After reading your manuscript, the reader should be able to duplicate your study design and results. Regarding the data, be sure to include:
  • All data related to the study sample (eg, race/ethnicity, education, socioeconomic status, etc)
  • Statistical analyses
  • Characteristics of diagnostic tests
  • Study limitations (eg, sample size, type of data, low response rate).
  It is also important to present your data clearly:
  • Write in short, direct sentences
  • Try to present as much data as possible, and in short tables and figures
  • Report data comparisons clearly (for example, actual “raw” data as well as absolute or relative risk reduction, confidence intervals as well as P values).

Finally, consult checklists used by journal editors, such as the Consolidated Standards of Reporting Trials (CONSORT), the Quality of Reporting of Meta-analyses (QUOROM), the Meta-analysis of Observational Studies in Epidemiology (MOOSE), and the Standards for Reporting of Diagnostic Accuracy (STARD).

“I had come to an entirely erroneous conclusion which shows, my dear Watson,
how dangerous it always is to reason from insufficient data.”
Sir Arthur Conan Doyle (1859–1930)

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By Clare Gurton (cgurton@rxcomms.com)

Here we summarise a recent article from ISPOR Connections 2006; December 15: 3–5

Patients are generally not included in decision-making yet they are the group to whom the benefits and risk of treatment apply. Treatment decision-making policy and treatment guidelines are led by objective evidence of benefit, that outweighs any risks, are collected from clinical studies under conditions of an experiment rather than clinical practice, and are designed to satisfy regulatory requirements prior to approval. The question is: how to include end-users and to generate a valid way of assessing the preferences of a representative sample of the patient population and, further, to incorporate their preferences into risk/benefit decisions.

In a recent article, Hauber et al discuss two approaches for overcoming this problem. The incremental net health benefits (INHB) approach has been used in two recent studies. It quantifies the benefits and adverse events of a treatment and assigns weights to each outcome. The difference between the sum of the weighted benefits and weighted risks represents the net health benefit and the INHB is calculated as the difference between the net health benefit of the treatment under assessment and a comparative treatment (most often standard care).

Another approach is to calculate the maximum acceptable risk (MAR). This estimates the maximum risk that patients are willing to tolerate in order to achieve the therapeutic benefits of a treatment that incorporates patient preferences over risk and benefit outcomes. The MAR can then be compared with actual or expected risk to determine patient acceptability. MAR is calculated using choice experiment or conjoint-analysis methods and so includes patient’s subjective assessment of the risks versus benefits directly; MAR is the patients’ appraisal of the risk level at which the benefits are zero.

Both of these methods are relatively new and there is little data on their use in practice; however, they highlight the increasing importance of quantifiable patient preferences in risk/benefit analysis.

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In praise of eloquence

By David Woods (dwoods@rxcomms.com)

Calliope (one of the nine daughters of Zeus and Mnemosyne) – the Muse of epic poetry and eloquence

When the body of Shakespeare's Julius Caesar is brought before the Romans, does the bard have them say “Whodunnit?” No, he has Mark Antony deliver the eloquent “Friends, Romans, Countrymen” speech. And the Roman poet Horace showed his lyrical skill with: “Pick today's fruits, not relying on the future in the slightest.” Carpe diem. He did not, you will note, say “Have a nice day.”

Not only has eloquence departed, but so it seems has simple direct speech. And is it any wonder when many university students can’t construct a coherent sentence, and ‘remedial English’ is a regular part of the college curriculum?

Allan Bloom, author of “The Closing of the American Mind,” thinks this is because students have lost the practice of reading; they want to be thought “authentic” by having few cultural pretensions and by refusing to make what they see as “hypocritical ritual bows to high culture.” This, in turn, says Bloom, is because schools have failed to persuade students to read – let alone to like it. And this leads not only to loss of precision and colour in language, but also to a defensive posture that language doesn't matter.

Thus, when I’m urged to observe the No Smoking sign or, worse still, to adhere to it... it sinks in that imprecise language occurs when people don't think first about exactly what it is they want to say. Either that, or it’s a lack of vocabulary that can be papered over by such excrescences as the prevalent and ubiquitous “like,” as in “I’m not – like – into reading.”

Language is the most expressive and subtle instrument of communication that exists. Scientists, however, often sprinkle their language with jargon in trying to show that they're doing something important. And politicians – who, heaven knows, should be masters of oratory – contribute to the decline of eloquence. George Orwell, whose prose was eloquently clear and direct, believed that the great enemy of clear language is insincerity. He suggested that political language consists largely of euphemism, question begging and cloudiness. He gives a wonderful example of the decline of eloquence, starting by quoting the well-known verse from Ecclesiastes: “I returned and saw under the sun, that the race is not to the swift, nor the battle to the strong, neither yet bread to the wise, nor yet riches to men of understanding, nor yet favour to men of skill; but time and chance happeneth to them all.”

He translates this into modern English, as follows: “Objective consideration of contemporary phenomena compels the conclusion that success or failure in competitive activities exhibits no tendency to be commensurate with innate capacity, but that a considerable element of the unpredictable must invariably be taken into account.”

Why this decline in eloquence? In part it’s the failure of schools to teach reading and language skills; it's also the lowest common denominator language of television and, increasingly, of newspapers. I fear that it may also have to do with notions of egalitarianism: that to speak with clarity and verve is somehow elitist or effete.

Part of the solution might be a renewed respect for graceful speech and writing. This will be attained by proper and early teaching, wide and eclectic reading; and perhaps, in the interim, by ridiculing or satirising the sloppy language that is the product of sloppy thinking and that makes for mighty dull listening.

“Talking and eloquence are not the same," said Ben Jonson. “To speak, and to speak well, are two things.”

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Industry commentary – Predictors of productivity

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Next month

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David Woods and the Rx Communications team

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