Clinical Evidence

With a team of data managers, physicians, medical statisticians and statistical programmers, and medical writers, Clinical Science supports innovation translation at the AO with clinical evidence grounded in sound scientific methodology. In close collaboration with other AO ITC business units, Clinical Science is part of an efficient pathway to transform ideas into published clinical evidence.

Aside from providing internal services in methodological, statistical, literature, and regulatory support of clinical studies, Clinical Science has been the driving force behind the newly launched AO Global Data initiative.

AO Global Data: poised to revolutionize medical data collection and drive innovation

Delivering value to patients and society is at the heart of acclaimed London orthopedic surgeon Simon Lambert’s mission. With more than 35 years of clinical experience, 100-plus peer-reviewed publications, 20 book chapters—including a revision of Gray’s Anatomy chapters on the shoulder girdle and shoulder joint—to his credit and a keen interest in innovation, Lambert explains why he is a champion and early adopter of AO Global Data, the new AO initiative offering surgeons participation in and access to the world’s largest and most comprehensive orthopedic outcomes database.

How did you come to the AO and to the AO Technical Commission Upper Extremity Expert Group (UEEG), which you chair?

My AO career began in education when, as a student, I took my first AO basic course in 1982. Later I introduced AO operating room personnel (ORP) courses into my training program hospital, and subsequently advanced to become a faculty member and chair for AO courses in the United Kingdom, Davos, Switzerland, and internationally. I served under Prof Norbert Suedkamp from 1998 to 2013 and succeeded him as chair of the AO Technical Commission UEEG. I got to know great colleagues at the AO Research Institute (ARI) and AO Clinical Investigation and Documentation, now part of the AO Innovation Translation Center, and undertook research relevant to the UEEGs’ goals of innovation and development in the field of upper extremity trauma. During this research, and through other experience in outcomes research, I came to appreciate the value of developing questions using high-quality data. Given this background, I am very much a champion of the opportunities afforded by AO Global Data.

Regarding patient-reported outcomes (PROs), what are some of the challenges/needs surgeons currently face in their daily clinical practices?

Most important is justification of what we do in terms of the value to an individual and society. There are lots of things we like to do, but we don’t know what value they bring to an individual or to the community. In terms of orthopedics, what we believe we do is resolve people’s painful impairments which lead to disability and therefore represent a cost to them and to society. Our challenge is to justify our interventions in terms of cost effectiveness for the patient and then financial cost effectiveness, and the only way to do that is to measure outcomes.

Historically, in outcomes, the surgeon has liked to measure, for example, how much angle something bends more than it did before an intervention, or how much distance someone can walk, or how much pain the patient experiences. What that didn’t do was drill down into what actually the patient recognized as value. All those objective, observer-based parameters assume that they are what the patients find important in their lives, and they are not always valuable. Some people are prepared to put up with a certain level of discomfort if they can achieve a certain level of social independence; other people are very much disabled by pain and find themselves unable to become socially independent. So, there are huge, interpersonal variations, and PROs try to expose that: Per patient, is there a value in that intervention? And from that, we can gain some insight into how useful the intervention is.

How can AO Global Data help resolve these challenges/meet these needs and serve surgeons in their daily clinical practice?

As a tool to collect vast amounts of data across a number of different communities, AO Global Data can allow us to see common dominators, understand the demographics and what matters to patients, and how to better meet their needs. There is a clear recognition within the AO and by its industrial partners that fixation techniques and technologies are only part of the answer. Factors, such as rehabilitation, reintegration into society, functional independence are quite difficult to elucidate. By adding patient-reported outcomes, such as the Patient-Reported Outcome Measurement System (PROMIS) scores, we start to get not just the functional outcome, but psychological and personal impacts as well.

AO Global Data makes it easy for clinicians to collect patient-reported data: The only thing the surgeon does is fill in the metadata; the rest is generated by the patients themselves. AO Global Data also allows us to get information remotely, instead of bringing the patient back to the clinic.

How can AO Global Data support the AO Technical Commission to gather clinical evidence for innovation?

When we develop something, either a derivative of an existing device or revolutionary, we currently understand it in small, prospective cohorts which cannot be randomized very easily, so we don’t have a clear feeling of the effect size of an intervention. AO Global Data allows us to engage more centers with clinical questions, to introduce innovation into a bigger sphere, and to put that data to work. Musculoskeletal health is arguably the biggest cost to society across the world, in trauma, metabolic bone disease, and degenerative disease, and in terms of the economically important population. Many regions of the world, China and India for instance, have huge populations at risk of the health and economic effects of osteoporosis, but we don’t know clearly how we can help to improve the health of those populations. AO Global Data will help illuminate such areas of need.

As a solution for gathering PROs, how is AO Global Data unique or better than existing solutions?

AO Global Data’s uniqueness lies in the first two letters of its name: AO. The AO has a credibility that is independent of commercial, university, or governmental interests. It reaches more than 225,000 surgeons globally per year, so its footprint in terms of education, research, and innovation is far and away the biggest of any organization. And it has this vision of making life better for patients. AO Global Data can drive innovation because we can respond to what it tells us. The information is relevant to the real-time management of the patient, not just to future documentation and research. For more information see AO Global Data.

“AO Global Data puts data to work as an innovation driver.”

Simon Lambert, Chairperson of the AO Technical Commission Upper Extremity Global Expert Committee and Upper Extremity Expert Group

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