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“Where are we today? Are our patients whom we treat today any better off than 10- 20 years ago? We may believe they are but do we, in fact, have any evidence to prove that they are? These are all important questions, tough as they are, to ask of us. In any academic endeavor one of the most difficult tasks is to embark on a detailed self-evaluation” ICRS 2004, President’s Report Dr Shawn O’Driscoll
“Demonstration of pervasive and persistent unexplained variability in clinical practice and high rates of inappropriate care, combined with increasing health care expenditure have fueled a steadily increasing demand for evidence of clinical effectiveness - As a result increased attention is being directed to the development of methods that can provide valid and reliable information about what works best” JAMA Sept 04 Vol 290 No 12
Evidence Based Medicine • Buzz word of the 90’s – epidemiology, cost and patient driven • “Evidence-based medicine is about proving things - but it is really about transparency - being clear about what we know and don't know” * • Orthopaedics - art and science converge, and unpredictable patient compliance can affect outcome – not so clear cut * Business Week 29/5/06 Dr Paul Wallace CMO Kaiser Healthcare USA
Clinical trials • Considered the Gold Standard but how realistic are they in orthopaedics? • JAMA article quotes that up to 1/3rd lead to conclusions that are overturned • By the time the results come in, science and medicine may have moved on, making the findings less relevant – e.g ACI JAMA Sept 04 Vol 290 No 12
Few trials provide data on long term effectiveness • What is the functional status of the patient – great biopsy but ? • Are the patients and surgeons in the trial typical of the practice or community setting? • Often many exclusions to avoid contamination and poor results in study
Why collect outcomes? • Does the device work? And in your hands • Earlier warning of problems • Patients are more demanding • Payers may not pay for new technology • Competition • YOU be the first to know what is happening with your patients
Often no efficacy trials for the emerging technologies – e.g autologous procedures - are they even safe ? Existing technologies undergo changes – are they still the same ? Does it work the same in your hands? Many examples of “approved” devices with disastrous results for patients Technology
You cant rely on the regulatory system • Regulatory 510k allows substantial equivalence to change devices over time. • An axe can change to a chainsaw over time without any additional trials for safety and efficacy
Someone may already be following your patients • Insurance companies • Hospital administrators • Patients themselves • Lawyers • Out of context, and in the wrong hands the scores can be misleading and damaging to surgeons.
Same operation different outcome score – do they understand why?
Know what you want • Does it allow you to collect what you want? Needs change over time, and between patient groups. • Can you extract the data without needing programmers, PhD's? • Ideally be able to run routine reports without needing additional resources • Does it include all the surveys/scores you may want to use? • Who OWNS the data?
Is there flexibility to add your own unique requirements? • Has it been tailor made for Orthopaedics? Those adapted from other indications tend to be clumsy and ineffective. • Has the company supporting it been around for a while? • Do they provide good support? • Are they independent of implant companies?
Data Entry is very important • Should be able to offer different options – manual data entry, scannable forms (OCR) technology, and web based for patients to enter data. • Not all patients will manage web based
Local • Requires some IT support to maintain server and installed software. • You OWN your own data, no-one has access without you knowing about it. • Remote log is possible for web access but a local set up required to allow remote access • Secure back up of data essential • Full control of all HIPPAA issues and manage your own security
Remote/Cloud • Who owns the data? • Who else has access to it? • If a company is involved is it perceived to be unbiased? • Site not in control of all HIPAA issues • Back up taken care of by hosting company • What happens to your data if you stop using the system? • Can you run your own reports and extract all your own data?
Getting started • Need commitment • Be realistic – it costs $ and takes time - YOURS too • How much data do you need to collect? • Start conservative - don’t try to collect data on everything at once. • Spend some time to understand the features of the system you choose
The right program makes is EASIER, not EASY. • The initial period is painful – it gets easier once it becomes part of your routine • Do you have any help? Sites with more than one surgeon usually need a research coordinator, at least part time • Don’t overload your existing personnel
Positive side • Patients don’t mind being asked to complete questionnaires • Web entry should improve response rate • It can change your practice • Knowledge is power • Its very rewarding once you start to generate results
Its widespread use will result in more empirically founded publications on new and existing procedures, early detection of complications, and allow all surgeons to participate in studies. Ultimately, this will lead to verifiably improved outcomes for patients undergoing joint surgery.
Whatever you use should result in more empirically founded publications on new and existing procedures, early detection of complications, and allow all surgeons to participate in studies. Ultimately, this will lead to verifiably improved outcomes for patients undergoing joint surgery.
Dedicated Orthopaedic Software • Modules for Hip, Knee,Spine,Foot and Ankle, Upper Limb and Spine • Sports Medicine and Arthroplasty
Socrates enables you to collect • What you did • Why you did it • How you did it • What happened How much data is collected is up to the user
What you did • Surgery details – as much or as little as you want.
What happened - • Patients perspective – subjective • Surgeon – objective ROM, clinical assessment • Radiological
Most scores can also be entered directly using a standard scanner
Other Features • Basic descriptive statistics included • X-rays/electronic document storage • Standard reports • Import basic data from other EMR’s • Export all date for analysis in stats package
Multi centre studies possible • Data can easily be extracted into subsets and combined with other Socrates users data for multi centre studies.
