Clinical guidelines – gentle persuasion or statutory regulation?

Issue: Issue 2 2005

ByDavid L. Hamblen, PhD, FRCS

David L. Hamblen, PhD, FRCS [photo] --- David L. Hamblen, PhD, FRCS

One of the stories reported in this issue of Orthopaedics Today deals with the controversy surrounding the role of clinical guidelines in controlling the practice of orthopaedic surgery in the British National Health Service. (Please see related story: Surgeons question efficacy of NICE guidances in this issue.)

In 1999, the U.K. government established a National Institute for Clinical Excellence (NICE) to evaluate new technologies and to issue guidance on how their benefits compare with existing methods of diagnosis and treatment. The aim of this unique initiative: to improve the standards of care for patients across the whole of the NHS and to reduce geographic inequalities in accessing new innovative treatments.

To date, the government has published more than 50 guidelines across a wide range of disciplines with others in preparation. Those relevant to orthopaedics include the following: hip replacement prostheses, prevention of secondary osteoporotic fractures, and metal-on-metal hip resurfacing arthroplasty. More recently the authorities have given preliminary guidance on minimally invasive surgery for hip and knee replacement.

Resisting new rules

Inevitably, some clinicians view the introduction of guidelines as an attempt to interfere with their freedom to practice independently, and to undermine their relationship with patients. The guidance has also met with resistance from some health authorities, particularly those facing funding deficits who prefer to spend their limited budgets on cheaper, well-established alternatives.

All health care providers, whether private companies or public services, face rising costs from the explosive expansion in new drugs and high-tech procedures for diagnosis and treatment. Both groups have an interest in providing the best care available to the patient populations they serve while remaining within budgets. The problem is how to define what constitutes “best care” in a rapidly changing world of health care technology.

Health economists attempt to do this by using measures of value for money, but this depends on sufficient reliable results from evidence-based medicine studies. In orthopaedic surgery in particular, getting solid evidence may need much longer follow-up than the customary one to two years required to identify early complications, that in the main are unaffected by new technologies.

Recent published surveys, based on audit of case records, have cast doubt on the extent of implementation of much of the published NICE guidance, and in the case of choice of hip prosthesis have shown no effect. This may reflect resistance by individual surgeons who feel that the advice failed to recognize the complexity of hip surgery, or were persuaded that new, more expensive technologies must inevitably be better. Manufacturers for their part will promote new designs and materials to sell in sufficient numbers to recover development and manufacturing costs.

Regulation of the manufacture and safety standards of new drugs and implants are now tightly controlled in most countries. Control of their use is far more variable and ideally should not be subject to restrictive legislation. However, in the face of mounting costs, expect pressure from both governments and health care providers to impose such restrictions.

There is no easy compromise solution, but guidelines are more likely to be accepted by clinicians when based on reliable clinical evidence subjected to review by a peer group from their own specialty.

The development of national joint registries as a tool for clinical audit, and providing a strong role for specialist associations in ensuring that their members receive adequate training in new technologies are essential steps in achieving this outcome. Above all, patients must be fully informed on the nature of new procedures and the degree of uncertainty about their safety and efficacy. Failure to do so will lead to further restrictions on the freedom of individual surgeons to choose the procedure they feel their patient deserves.

David L. Hamblen, PhD, FRCS, is emeritus professor of orthopaedic surgery at the University of Glasgow and visiting professor to the University of Strathclyde in the Prosthetics and Orthotics Centre in Scotland. He is a past chairman of the Orthopaedics Today Editorial Board.