Moderator: Ronald G. Donelson, MD, MS
The spine has a very limited vocabulary for expressing that something is wrong. Low back pain (LBP) therefore reflects many different conditions. Unfortunately, imprecise diagnoses complicate treatment selection and decrease treatment effectiveness.
Spine care research has been locked in a search for the best treatment for a non-specific symptom, satisfied for decades with analyzing randomized clinical trial (RCT) group means in large heterogeneous samples. Two questions then arise: Have RCTs improved or impeded the quality of care for LBP patients? Are LBP patients better off now than they were 30 years ago?
Meanwhile, two large international surveys of LBP researchers reveal that the highest research priority is the identification and validation of subgroups of more homogeneous patients, perhaps independent of making a structural/anatomic diagnosis. Although subgroup-specific studies have proliferated, most spine clinicians and even LBP clinical guidelines do not appreciate their primary role in moving us toward individualized care.
We need to escape from one-size-fits-all treatments of this regional symptom in favor of treatment decisions based on individual patient’s characteristics. For RCTs rich in information and sample size, post hoc subgroup analyses can produce useful findings by using baseline patient characteristics to create a more homogeneous cohort with treatment effects re-evaluated relative to outcomes measured. However, the rare a priori or preplanned identification of homogeneous subgroups based on a more precise diagnosis has particular value.
The first necessary research step is demonstrating inter-examiner reliability in identifying members and non-members of each clinical syndrome or subgroup. Each reliable syndrome then requires validation, first with preliminary prospective cohort studies followed by RCTs that randomize members of that syndrome.
The Levels of Evidence paradigm, intended to both guide and evaluate research design and quality, does not include or acknowledge the fundamental importance of reliability studies, instead focusing on the need for a gold standard for diagnosis, which unfortunately and ironically does not exist for most LBP. Each validated syndrome or subgroup, even for non-anatomic-based criteria, needs its own diagnostic gold standard. This will also decrease the number of patients that have no diagnosis, i.e. have non-specific LBP.
With no anatomic basis for diagnosing the cause of most LBP, new research and diagnostic paradigms are required in order to identify and validate these clinical syndromes or subgroups. Subgroup-specific RCTs are essential vs. more non-specific RCTs that will simply perpetuate our past lack of progress. We also present a real-life example of an innovative “precise” spinal diagnosis identifying individualized treatments leading to predictably good and well-documented outcomes.
Upon completion of this session, participants should gain strategies to:
- Examine the consequences of a precise versus imprecise diagnosis on treatment selection and outcomes;
- Compare the strengths and weaknesses of RCTs in helping decision-making when treating individuals;
- Review the types of research studies essential to identifying and validating low back pain subgroups;
- Debate the strengths and weaknesses of the “Level of Evidence” construct in guiding and evaluating subgroup-specific research;
- Analyze a real-life example of a standardized, predictably-effective, individualized treatment resulting from making a “precise” spinal diagnosis.
Agenda
- What Comprises a “Precise” Spinal Diagnosis? The Key to Effective Individualized Care
Ronald G. Donelson, MD, MS
- How to Establish and Validate a Precise Diagnosis: The Essential Research Pathway toward More Individualized Care
Kevin F. Spratt, PhD
- Diagnostic Gold Standard: Currently Missing-In-Action for Most Low Back Pain
Jon D. Lurie, MD, MS
- Debate: The Current “Levels of Evidence” Construct is Advancing the Quality of Patient Care
Pro: Jon D. Lurie, MD, MS
Con: Kevin Spratt, PhD
- A “Precise” Diagnosis Identifying a Standardized, Predictably-Effective, Individualized Treatment: A Real-Life Example
Ronald G. Donelson, MD, MS
- Proposed Action Steps
F. Todd Wetzel, MD
- Discussion, Questions and Answers