Healthcare is becoming more evidence-based and providers from around the country are gathering data with electronic medical records to show their treatments — surgical or not — produce good outcomes and are cost-effective.
For years, the strongest evidence was based on randomized controlled trials that focused on a narrow, homogeneous population to report outcomes; these trials aren't predictive of all patients in all healthcare settings, but yet insurers base coverage decisions on their outcomes. Every individual patient has unique variables associated with their cases, and every surgeon brings a different level of experience and expertise to the operating room.
"Our society currently lacks information for evidence-based medicine in spine," says Zoher Ghogawala, MD, co-chair of Lahey Health's Comparative Effectiveness Research Institute. "The patients in this CSM-S trial are undergoing established treatments and hopefully we'll be able to increase transparency regarding the best treatments in the field. At the same time, we are preparing for the future when we'll have a greater degree of information to guide therapy."
Individual providers and large groups are developing registries to compile data about hundreds of cases and allowing individual surgeons to see how patients similar to the ones in front of them reacted to different treatment performed by different specialists; even performed by themselves.
"There is an enormous magnitude of spinal problems and treatment options for back pain patients," says Dr. Ghogawala. "For the most part, we don't have good data to show which treatment or which combination of treatments will produce the best results. No registry can capture all the information we need, but using validated outcomes tools to get an assessment of the overall healthcare quality of life of patients is an important step. These data should be shared with other clinicians and patients when the data is relevant."
Dr. Ghogawala and his colleagues are developing a registry effort that combines clinical and patient-reported data with expertise from clinician experts on how to approach new cases in an attempt to give patients a better estimate of their outcomes with each treatment option. His efforts specifically focus on patients with cervical myelopathy disorders.
"We are capturing the radiographic data and looking at how patients are doing with the health quality related to life, allowing each patient in the registry to have their images reviewed by 15 different surgeons," says Dr. Ghogawala. "If greater than 80 percent of the surgeons come up with the same treatment plan, that's what we should do. If there isn't a consensus, we explain that to the patients and discuss their options because there is real uncertainty about what we should recommend."
The National Institutes of Health and the PCORI support this registry effort, hoping to identify the best treatment possible for patients given the unique aspects of each case. A third philanthropic group supports the researchers in collecting cost-effectiveness data. Patients also participated in the study design and offered valuable insight into what makes an impact on their quality of life.
"We spent around three years doing a pilot study and having investigator meetings to develop registry efforts, but it wasn't until we sat down with real patients that we understood the different amounts of pain they felt following spine surgery and that this type of pain was a key factor in the overall quality of life," says Dr. Ghogawala. "As surgeons, when treating cervical spinal cord compression, we are focused on improvement in spinal cord function; but it turns out that the overall sagittal alignment of the spine following surgery appears to affect overall pain and health-related quality of life. If we hadn't received this feedback from patients (using validated health-related quality of life outcomes tools), we wouldn't have focused on spinal alignment in our study. It may, in fact, turn out to be one of the most important aspects of the trial."
There are 11 centers participating in the study, and each time a patient enrolls, their images are sent to the 15 surgeon experts on the review board. The surgeon reviews the X-rays and answers questions about the surgical approach. Surgeons can respond within 72 hours of receiving the email, and most responses take 15 seconds.
"The hope is that by providing outcomes data and health resource utilization data to patients, hospitals and doctors and payers, we'll all be able to use this data to advance clinical care," says Dr. Ghogawala. "But we will also be able to impress upon payers the really efficient aspects of care and which aspects are cost-effective."
Patient-reported outcomes and the outpatient experience are another important part of the registry efforts. Surgeons are often concerned about the inpatient experience—how long the operation takes and what the risks are—but the outpatient experience is equally as important.
"How durable is the outcome? Are there factors that will limit their recovery? Is an injection treatment helpful?" says Dr. Ghogawala. "Our effort here is to record all of these factors as well as the costs associated with outpatient and inpatient treatments to provide a higher level of understanding for our patients and stakeholders."
The trial will accrue patients for 18 months and continue to analyze results. "There is a real opportunity to bring the best we have in terms of medical knowledge using internet-based technology. It might become easier to provide information to patients far away from us," says Dr. Ghogawala. "We are looking at cervical myelopathy today and are comparing costly treatments that are used widely in the United States, but treatment strategies in the rest of the world appear to cost much less. This is an opportunity for us to form a carefully vetted network of physicians from around the world to share expertise."
Dr. Ghogawala and his team also regularly communicate with other specialists — such as neurovascular and cardiovascular specialists — to see what is working well for them and whether similar methodology could be applied in other areas. Dr. Ghogawala's biggest advice for surgeons looking deeply into evidence-based registries: get patients involved.
"It sounds daunting, but at least for me from personal experience, there is no question that the patient's perspective on how successful the treatment is really matters. It has become absolutely vital to consider patient quality of life in order to determine whether we should do one operation instead of another," he says.
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