Practice Guidelines

Recommendations for management of medical conditions are as old as the healing profession.

Traditionally, “experts” or specialty societies would advocate particular methods of treatment without verifying outcome. How such recommendations were derived remained obscure.

During the second half of the 20^th century, the basis of such pronouncements became more explicit, culminating in the first decade of Evidence Based Medicine (EBM), the nineties.

Informal and formal consensus statements by acknowledged leaders of a clinical specialty or subspecialty remain the basis of some current Guidelines.

Through the nineties, Evidence Based Medicine spawned Clinical Practice Guidelines (CPG) that are underpinned by clinical research. However, that research is of variable quality.

Since few traditional medical interventions have been validated by clinical study, many current Guidelines are hybrids of consensus and scientific evidence.

Progress in the development of CPGs has been slow for a variety of intrinsic reasons².

Practice Point

Barriers to CPG Development:

1. size and complexity of the research
2. difficulties in developing evidence based clinical policy
3. difficulties in applying evidence in practice:

a. access to evidence and guidelines
b. organisational barriers

Quality of Guidelines

Many Clinical Practice Guidelines (CPG) do not document the strength of evidence on which they are based.

Reviews of Guidelines developed for the United Kingdom^3,4, international use⁵ and Canada⁶ demonstrated that, although descriptions of the developers were of better quality, details of the evidence and estimates of the strength of that evidence were generally lacking.

For the Canadian study⁶, there was little sign that the quality of the Guidelines improved between the beginning (1994) and the end (1998) of the study period.

This lack of rigor in the development of CPGs can result in such inconsistency that reliability of any Guideline cannot and should not be assumed.

Practice Point

If a CPG is being offered as evidence for prosecution or defence, opposing counsel should critique the EBM quality

Thus, for a common condition the proportion of patients selected to receive a standard treatment would have been between 13% and 100% depending on which of 20 different Guidelines was selected⁷.

Use in medical malpractice litigation

Both plaintiff and defence counsel should be very cautious in using current Guidelines for litigation purposes.

While it is true that CPGs do not represent community standards, they are potentially applicable as evidence in medical malpractice litigation.

Indeed, a substantial minority of plaintiff counsel use CPGs informally in screening potential medical malpractice Actions for viability⁸.

At the beginning of the era of Evidence Based Medicine (EBM) in the early nineties, a writer⁹ identified 4 prerequisites for Clinical Practice Guidelines (CPG) to have meaningful medicolegal impact.

Practice Point

Medicolegally relevant CPGs:

1. for frequently litigated conditions
2. widely accepted by physicians
3. fully integrated into clinical practice
4. easily interpreted in a litigation setting

Plaintiff lawyers began to offer CPGs as formal evidence in medical malpractice litigation before they were generally adopted by physicians.

Even though CPGs have subsequently been introduced into only a tiny proportion of medical malpractice trials⁸, such litigious usage has chilled a medical profession that was already only lukewarm about generating and adopting Guidelines.

In a few US states, proponents of CPGs have successfully lobbied to have them legitimised as shield but not as sword.

It remains to be seen whether this move will prove effective in warming physicians to more widespread adoption.

Some Guidelines are being developed with a distinctly defensive flavour. Until and unless there is regulation, or at least quality control, radical groups of physicians can attempt to legitimise their viewpoints with CPG for a “respectable minority”.

Even professional societies that represent the majority of a medical specialty are producing Guidelines that are permissive rather than true to research findings or formal consensus.

Utilisation Review protocols must be clearly distinguished from CPGs¹⁰. Here, the primary motivation is not “best medicine” but cost-constraint.

Thus, not only do current Guidelines derive from research with a wide range of scientific validity, but other motivations may contaminate their claims to represent “best medicine”.