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Revolutionary Overthrow Of Compliance¹ Concept Delayed

Bringing down the current concept of  patient compliance and replacing it with a functional set of principles is taking for-freaking-ever.

The current hangup is the manifesto. Any revolution worth its salt has to have a manifesto. Since it’s not the sort of thing  one can knock off on a Saturday afternoon while watching college football on TV, it’s hardly a surprise that composing a manifesto requires time and effort.

But, it turns out that just designing and printing a manifesto in a format that bespeaks authority yet is simultaneously cool in that ironically subversive way, the stylistic goal to which the really hip manifestos aspire, is no small task.  The bids for engraving the final product on stone tablets came back way over budget so I have to rework the publication process, substituting simulated calligraphy on recycled parchment for chiseled granite. That should reduce costs considerably, but it all takes time.

While awaiting the completion of the manifesto and the beginning of the revolution, however, much can be done to (partially) rehabilitate patient compliance into a concept that is, if not an efficacious construct, at least one that is more useful, less likely to result in mistakes and misunderstandings, and – well, less embarrassing.

Things To Do Until The Manifesto Is Finished

Starting with this entry and continuing for the next several posts, I will introduce, one at a time, principles which are simple and inexpensive to implement in any context yet can massively improve the field of treatment adherence.

Moreover, these axioms are  so self-apparent – and should, in fact, have been in use for years – that the failure to implement them should be a res ipsa loquitur case of fundamental miscommunication, whether intentional or unintentional,  and/or profoundly flawed scientific method.

Step #1: Always provide context-pertinent definitions of Patient Compliance terminology

The choice of Patient Compliance terminology (e.g, “compliance,” “adherence,” “concordance,” etc.) is a matter of taste.  Provision of context-pertinent definitions of those terms in every case in which they are published is invariably an obligation.

This is, as advertised, a simple proposition: because there are no standard definitions of “compliance,” “adherence,” “concordance,” etc.,  that apply universally, using one or more of these terms (or their negatives) in any formal or informal publication (including but not limited to articles,  press releases, abstracts, advertisements, white papers, editorials, dissertations, studies, feature stories in the lay press, and poster sessions), obligates the author to define those words pertinent to their context.

A key feature of this step is the bypassing of the inevitably interminable debates over the “correct” definitions and the inevitably unsuccessful efforts to coerce everyone in the field to follow the mandated official Glossary Of  Patient Compliance Terminology.  Authors, researchers, marketers, clinicians, professors, and anyone else dealing with the field can use terms to mean whatever they prefer – as long as those meanings are clearly explained.

“Context-pertinent” means the definition must be sufficient to allow a reader to understand precisely what behavior qualifies as “adherence” or “non-adherence” in the circumstances described by the article or advertisement.

A press release, for example, claiming a medication program results in “95% Adherence” would necessarily  include an explanation of “adherence” as used in the copy (e.g, “For the purposes of this report, adherence is the percentage of patients who reported taking at least 80% of their medications every week over a period of 6 months”).²

This is fundamental and essential information, yet by my casual count, it is absent from more than 75% of the press releases and promotional pieces that include claims of high or improved compliance. And, that fundamental and essential information is absent in a discouragingly large fraction of the scientific literature I peruse.³

One of the advantages of always providing definitions of adherence terminology is that nonspecific (or vague or  nebulous or vacuous)  applications of these words are acceptable as long as it’s made clear that the usage is nonspecific (or vague or nebulous or vacuous). Those four-color brochures about the  6th format of a medication can still boast that “Medication X is now available in once a day dose for better compliance,” simply by adding, “‘Better compliance’  in this case means we think, based on some studies, none of which involved Medication X, patients will, one way or another, be more likely to take the right dose at the right time  with the once a day dose as compared to patients taking the same medication two or more times a day.”⁴

The definitions can be within the text, in a footnote, part of a glossary on a sidebar, … as long as they are obvious and, most importantly, available in every publication format. The abstracts of scientific papers, for example, must include the definitions since they may be published independently of the paper itself. And no fair writing that “definitions are available on request.”

Advantages Of Implementing Step #1 – Inclusion Of Definitions

Being certain about what a study or a press release means by the words “improved adherence” seems, from my perspective, itself sufficient  justification for implementing this step. Studies can be compared, anomalies understood, and the significance of findings determined. (I would also have fewer emails to write, asking for missing data.)

But there are other potential gains.

With luck, for example, the automatic inclusion of definitions might detoxify some of  the terminology and might even decrease the noise level of the arguments about which synonym of adherence is most coercive and condescending.

Perhaps best of all, the altogether reasonable expectation that publications about compliance include definitions of the pertinent terminology would go far toward eliminating much of the confusion and conflicting claims that plague the clinical, research, and commercial aspects of the treatment adherence concept and preclude most unintentional miscommunication about compliance and at least render the creation of  intentionally misleading claims more difficult.

1. Compliance, as used in this post, denotes the concept rather than a specific case of patient compliance, i.e., the study of why patients do or do not follow their prescribed treatment regimen. Further, in this post, “compliance,” “adherence,” and “concordance” are used synonymously.↩
2. There is substantially more information that is required to justify this claim. That will be covered in future posts.↩
3. I should note that writing to the authors of the scientific papers nearly always yields the missing definitions although it does not excuse the failure to provide those definitions in the paper itself.   Email requesting missing definitions sent to those responsible for the press releases, regardless of that person’s profession, title, or academic appointment typically goes unanswered and most of the replies that are received boil down to “That’s proprietary information.”↩
4. I happen to believe in the fewer doses = better compliance equation. I also happen to believe that readers deserve to know which claims are scientifically proven, which are extrapolations from other work that conveniently leave out conflicting evidence, and which are the hopes, dreams, and fantasies of a someone writing copy for an ad.↩