Department of Orthopaedic Surgery

The Department of Orthopaedic Surgery offers services and programs through the following Divisions. Use these links to directly access all our Department sites.

Spine

Spine

Clinical Research

Spinal Disorders Clinical Outcomes

At the UCSF Spine Center, we pride ourselves in providing the finest treatment available for spinal conditions. Our surgeons provide the best surgical techniques and the highest quality of clinical care. For additional information about our clinical outcomes program, please visit our Clinical Outcomes page.

In order to continually provide this high level of care, our surgeons actively engage in research so that they can further their knowledge of the msot effective surgical techniques, factors that influence the course of spinal disorders and their treatment, and the impact that various treatments for spinal conditions have on the lives of their patients. One key factor that our doctors focus on is the end result, or outcomes, of specific treatments. These outcomes typically take into account the perspective of the patient and focus on practical things that are important to our patients, such as increased function and decreased pain.

One thorough and extensive way of researching these key factors is to institute an outcomes research program. At UCSF we have an extensive outcomes research program that focuses on connecting the caer our patients receive with the outcome of their treatment. By doing this research, we are developing better ways to measue and ultimately improve the quality of care.

Please take a moment to visit our links at the left to learn more about this very important program.

 

A look at Clinical Studies

 

What is a clinical study?

Clinical studies are considered the highest level of scientific evidence. Generally, they are studies that are tightly controlled and use people as the subjected of research. There are two major types of clinical studies, interventional and observational.

Interventional studies are typically called clinical trials and are studies where the patients involved in studies, or subjects, are assigned to a specific treatment. In this type fo trial, there ae usually two or more groups of patients receiving different types of treatments. the choice of treatment is usually chose by the head of the study, or principal investigator, or randomly assigned. This type of study allows different types of treatments to be compared and new treatments to be evaluated.

In observational studies, the treatment is chosen by the patient with their doctor and nothing about the patient’s regular, standard-of-care treatment is changed. In this type of study, the principal investigator simply observes and records the outcomes of different patient groups.

Why participate in a clinical study?

There are many reasons to participate in clinical studies. Participating in clinical studies can often allow patients to have access to new, cutting edge treatments that are not otherwise available. Additionally, many participants in clinical studies feel that they are able to take a more active role in their health care. Anyone who participates in clinical studies helps to advance medical science and research, which will help provide better treatments for current and future generations.

Who can participate in a clinical study?

Clinical studies have specific, individual guidelines about who can participate in the study. These are called “inclusion or exclusion criteria”. Inclusion criteria are the guidelines that define who may participate (e.g., patients with spinal stenosis) and exclusion criteria are guidelines that define who is not eligible to participate (e.g., patients under age 18). It is important that the inclusion/ exclusion criteria aer strictly followed in each study. This helps to keep the participating subjects safe and also guarantee that the researchers will be able to keep the scientific standards of the study high and accurately answer their research question.

What should people consider before participating in a clinical study?

According to the National Institutes of Health, people should know as much as possible about the clinical trial and feel comfortable asking the members of the health care team questions about it, the care expected while in a trial, and the cost of the trial. The following questions might be helpful for the participant to discuss with the health care team.

  • What is the purpose of the study?
  • Who is going to be in the study?
  • Why do researchers believe the experimental treatment being tested may be effective?
  • Has it been tested before?
  • What kinds of tests and experimental treatments are involved?
  • How do the possible risks, side effects and benefits in the study compare with my current treatment?
  • How might this trial affect my daily life?
  • How long will the trial last?
  • Will hospitalization be required?
  • Who will pay for the experimental treatment?
  • Will I be reimbursed for other expenses?
  • What type of long-term follow-up care is part of this study?
  • How will I know that the experimental treatment is working?
  • Will the results of the trial be provided to me?
  • Who will be in charge of my care?

A look at Outcomes Research

 

Why we look at Outcomes….

At the UCSF Spine Center, the “outcomes” obtained through our outcomes research program help us to measure what we would like our treatments to achieve – improvements in function, pain, and quality of life of our patients. By obtaining these outcomes, our physicians have a valuable method of following and measuring the progress of our patients and linking these results to specific types of conditions, treatments, and other factors so that, ultimately, we can optimize our care for each patient.

What is Outcomes Research?

According to the National Institutes of Health, outcomes research is research that “evaluates the impact of health care on the health outcomes of patients and populations… outcomes research emphasizes disease oriented evaluations of care delivered in general, real-world settings; multidisciplinary teams; and a wide range of outcomes, including mortality, morbidity, functional status, mental well-being, and other aspects of health-related quality of life.”

This type of research differs from the schema that most people hold when they think of research. In the past, clinicians have usually used tests in laboratories or well-designed and controlled clinical trials to determine whether a treatment is necessary and/or successful. The field of outcomes research came about when researchers and physicians realized that these controlled types of studies could overlook many of the things that matter most to patients, such as how much they can expect to improve after surgery. With outcomes research, all the data is typically “real-world” data and not data taken from a laboratory of tightly controlled and designed trials.

How is Outcomes Research used?

Outcomes research relies on informational collected from patients. These outcomes focus on healthcare from the perspective of the patient, as opposed to evaluations and measurements by physicians.

In recent years, there has been an increasing desire by physicians to learn more about the real world impact of the care they are providing. This is especially true for chronic conditions, like spinal disorders, whose treatment goals are to improve subjective factors, such as pain. The physicians at the UCSF Spine Center are dedicated to providing the best care; care that takes into account the perspective of their patients.

Another important factor relates to the rapidly changing modern medical practice. As part of this ongoing development, physicians recognize that they will be required to provide definitive evidence of the outcomes of the care they provide. This is called evidence-based medicine. Acquiring solid outcomes is a crucial building block for evidence-based medicine.

Generally,. outcomes research is used to:

  • Evaluate and compare the effectiveness of treatments
  • Measure the impact of treatments on the outcomes of patients
  • Evaluate the economic impact of treatments and link it to health outcomes (i.e. measure the cost-effectiveness of treatments)

Where can Outcomes Research take us?

The overarching goal of outcomes research is to gain information directly from patients to ensure that the treatments we provide give our patients meaningful changes in quality of life. This information also helps us to develop consequential practice guidelines and assists us in guiding physician decision-making by providing credible, objective evidence about the impact of treatment options.

Conducting and evaluating outcomes research is a valuable part of any academic medical practice. By providing a scientific way to measure the end results of medical care, the results of this research help physicians in various types of medical practices to make the most informed treatment evaluations for their patients. As the field of outcomes research continues to grow, so does our ability to scientifically evaluate treatments, both old and new, and to measure the end result of those treatments on the lives of real patients.

Why do I need to Fill out these FORMS?

The forms that we ask our patients to fill out at many of their visits make up a very important part of our UCSF spine research effort. These forms have been specifically tested to measure the health status and the impact of spinal disorders on patients’ health. Many other hospitals across the country that also do clinical research use these forms. This gives us a standard way to compare the results of different patients.

These forms are also very important, because they are specifically designed to measure the impact of a spinal problem on your health and also to measure how much your treatment has helped you. This helps us in our research because we can calculate how much better you are doing and this helps us evaluate from your perspective how you are feeling. This is an important factor in deciding if a particular treatment is good or bad. We ask you to fill out the forms because we would like to know your perspective and we need to be able to measure it to help others with spinal problems like yours. We thank you for your participation in our research – you are the most important part.

 

 

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