To be truly effective in a practical way, orthotic research needs to involve both technological research and clinical research, according to Christopher Morris, senior orthotist, Department of Orthotics, Nuffield Orthopaedic Centre and the University of Oxford, United Kingdom.
Orthoses are designed to overcome specific biomechanical problems with the aim of achieving clinical treatment goals, Morris explained concisely during a presentation at the 2004 Annual Meeting and Scientific Symposium of the American Academy of Orthotists & Prosthetists.
Technological research, which is undertaken by orthotists and bioengineers, involves finding plausible solutions to biomechanical problems, Morris elaborated. "However, solving biomechanical problems does not necessarily ensure that the clinical treatment goals are achieved; neither does it tell us whether the orthosis will be more effective than other interventions in achieving the same goals," he explained, adding, "To answer these questions, we need clinical research."
Enter evidence-based medicine (EBM). "A culture of evidence-based healthcare has been adopted internationally," Morris pointed out, calling attention to several consensus conferences convened by the International Society for Prosthetics & Orthotics (ISPO) to review the evidence for specific clinical applications of orthoses.
Why is evidence-based medicine becoming a global buzzword not only in orthotics and prosthetics, but also in healthcare generally? Both consumers and payers are demanding more evidence that treatments produce the desired outcomes - and that this can be proved.
So, just what is evidence-based medicine? According to the University of Illinois, evidence-based medicine has been defined as "...an approach to practicing medicine in which the clinician is aware of the evidence in support of clinical practice, and the strength of that evidence."
A clear, concise definition is offered by the University of Minnesota Evidence-Based Health Care Project (EBHC), "an approach in which clinicians and healthcare professionals utilize the current best evidence in making decisions about the care of patients." The university adds, "It involves continuously and systematically searching, appraising, and incorporating contemporaneous research findings into clinical practice." The university then makes a vital point. "The overall goal is improving patient care through lifelong learning."
The Centre for Evidence-Based Medicine (CEBM), University of Toronto, Canada, defines evidence-based medicine as "...the integration of best research evidence with clinical expertise and patient values." The CEBM then goes on to define best research evidence. "By 'best research evidence,' we mean clinically relevant research, often from the basic sciences of medicine, but especially from patient-centered clinical research into the accuracy and precision of diagnostic tests (including the clinical examination), the power of prognostic markers, and the efficacy and safety of therapeutic, rehabilitative, and preventive regimens." The center pointed out that new evidence from clinical research can invalidate previously accepted diagnostic tests and treatments, replacing them with new ones that are more powerful, accurate, and efficacious.
CEBM defines clinical expertise as "the ability to use our clinical skills and past experience to rapidly identify each patient's unique health state and diagnosis, their individual risks and benefits of potential interventions, and their personal value and expectations." To CEBM, patient values are "the unique preferences, concerns, and expectations each patient brings to a clinical encounter and which must be integrated into clinical decisions if they are to serve the patient."
When these three elements - best research evidence, clinical expertise, and patient values - are integrated, they form a diagnostic and therapeutic alliance, which optimizes clinical outcomes and quality of life, according to CEBM.
Poor Research-Clinical Error
So, what is the quality of research in O&P? Pretty poor, according to Morris. Most published orthotic research describes studies with small numbers of subjects, short follow-up periods, and inadequate controls for comparison, he asserted. "In fact, there remains a dearth of unbiased clinical research regarding the effectiveness of orthoses across the spectrum of their application," he said.
This poor methodological basis, according to Morris, leads to these errors of interpretation of findings: 1) "Believing there are benefits from orthoses when in fact there are not," or 2) "Rejecting using orthoses which may actually confer benefits."
Another complication arises when there's a choice between two orthoses, and one is more expensive. Morris raised the question of how the cost of the more expensive orthosis can be justified on the basis of health benefits without appropriate research. If clinical research is going to be conducted and results disseminated, then studies must be designed appropriately and reported transparently, he stressed.
Perthes Disease Kids: An Example
To graphically illustrate the need for orthotic research to evolve, Morris cited the example of children with Perthes disease. "In this degenerative condition of the hip, conventional wisdom for many years suggested that the limb should be unloaded and the hip abducted and internally rotated," he noted. "Despite the array of interesting and innovative devices designed to overcome the biomechanical problem, none demonstrated any measurable clinical treatment effect and, for the most part, have all been abandoned." Morris also pointed out the adverse psychosocial effect on the young patients who were encumbered with the ineffective equipment.
Why Isn't Research Better?
Several factors are responsible for the poor design of clinical trials in orthotics, according to Morris. He listed the limited resource capacity of orthotists to undertake research and that there are specific challenges to evaluating the effectiveness of orthoses in general. Also, some clinicians themselves become obstacles to research. "There are clinicians who perceive clinical research and evidence-based practice as either worthless or a threat to their clinical art and autonomy, rather than as the natural progression of a science."
Clinicians also can disregard the results of properly designed and conducted research studies. Morris cited the instance of a large randomized controlled trial evaluating different orthoses and footwear for treatment of asymptomatic flat feet in children. The result? "This study clearly showed that orthoses do not alter the natural history of flat feet," said Morris. "Despite this, there undoubtedly remain centers that routinely provide insoles and [shoes] with the intention of creating arches in the child's foot." He added, "So even when we have the evidence, there are implementation challenges of changing clinical practices."
Benefiting Manufacturers
Actually, sound research studies can benefit not only patients and practitioners, but also orthotic device manufacturers, Morris pointed out. "In orthotics we are being offered new components and materials but are unsure for which patients they work best, and also whether the increased cost is justified." He cited the new generation of "intelligent" knee joints as an example in which unbiased clinical research should be employed on a large scale to evaluate what the advantages are for specific patient groups.
"Commercially, once this information is identified and disseminated, not only will more patients benefit, but the companies will sell more products," he noted.
The alternative is that individual clinicians try new orthoses with one or two patients, usually in an unsystematic way, and often not funded or reported as a clinical experiment, Morris said. "Sadly, despite the enthusiasm and innovation involved in this activity, there is little contribution to the scientific basis of orthotics," he commented.
Research Vital to Patient Welfare
Morris again stressed the importance to patients and healthcare
purchases of how well orthoses achieve treatment goals, a
distinction from simply overcoming a biomechanical problem. "As
history has shown us, if we do not undertake this task, we will not
be sure whether we are harming our patients or improving their
health." Clinicians thus have a responsibility to be aware of
research findings and appraise their scientific merit, Morris
pointed out, urging, "When opportunities present themselves, we
should positively encourage or actively participate in clinical
research."
