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Outcomes in SCS Trials

This article explores the concept of outcomes in SCS trials, including the different types of outcomes, how they are measured, and the challenges associated with measuring them. It discusses efficacy outcomes in chronic pain, relevant outcomes in SCS trials related to safety, feasibility, and efficacy, and topics for further discussion.

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Outcomes in SCS Trials

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  1. Outcomes in SCS Trials Ali Rezai MD

  2. Clinical Trial Outcomes • What are outcomes? • What are the different types of outcomes? • How are they measured? • What are some of the challenges? • Outcomes in SCS trials

  3. What are “Outcomes”? • Outcomes are variables or data points measured in trials to determine the impact of an intervention on a certain measure • Safety, feasibility, tolerability, efficacy • Different audiences may be interested in different measures • Patients / families, healthcare providers, regulators, payors

  4. Different Types of Outcomes • Patient centric (subjective and objective) • Survival, subjective pain scores, quality of life, satisfaction • Surrogate – includes biomarkers • 6 minute walk distance – transplant or mortality • Cholesterol – cardiovascular mortality • Composite • Major adverse cardiac events (MACE); pain score + opioid dose reduction

  5. How are Outcomes Measured? • Patient reported • Pain NRS scores, subjective measures • Family reported • Pediatrics, Patients with cognitive deficits • Provider reported • Physical measures, objective measures

  6. Challenges of Outcomes • Different audiences disagree about the relevance / value of particular ones • Questions about validity of selected measures • Impact of placebo / sham on measuring outcomes • Generalizability to non-study conditions or populations • Variability and reliability of subjective measures (e.g. pain) • Uni-dimensional measures used for multi-dimensional constructs

  7. Efficacy Outcomes in Chronic Pain* • Pain • 11-point (0-10) numerical rating scale of pain intensity • Usage of rescue analgesics • Categorical rating of pain intensity (none, mild, moderate, severe) when necessary • Physical functioning (either one of two measures) – Multidimensional Pain Inventory Interference Scale or Brief Pain Inventory Interference Items • Emotional functioning (at least one of two measures) – Beck Depression Inventory or Profile of Mood States • Participant ratings of global improvement and satisfaction with treatment Patient Global Impression of Change • Symptoms and adverse events – Passive capture of spontaneously reported adverse events and symptoms and use of open-ended prompts • Participant disposition – Detailed information regarding participant recruitment and progress through the trial, including all information specified in the CONSORT guidelines *Dworkin, Pain 113 (2005) 9–19

  8. Relevant Outcomes in SCS Trials

  9. Safety • Procedure Related • Bleeding, infection, wound • Neurologic injury • Neurological • Sensory and motor deficits • Device Related • Infection, erosion, failed hardware, disconnection • Stimulation Related • Other • New pain syndromes • Worsening of pain • Poor hardware placement

  10. Feasibility • Impact considerations of treatment on patient and support system • Technical / procedural

  11. Efficacy – Pain Intensity • VAS • NRS • Faces • Dose of concomitant opioid or other analgesics • Responder analysis

  12. Efficacy – Pain Quality • McGill Pain Questionnaire (Short Form) • Pain Detect Questionnaire • Brief Pain Inventory

  13. Efficacy – Quality of Life / Functional • Patient Reported Outcomes Measurement Information System (PROMIS-29) • Oswestry disability index (ODI) • SF-36 • EQ5D • QALY • Days out of work

  14. Efficacy – Satisfaction with Treatment • Patient Satisfaction • Provider Satisfaction

  15. Topics for Discussion • Validity / Reliability • Placebo / sham effect • Generalizability • Duration of measurement: <3 months, 3, 6, 12, >12 months • When to include a responder analysis • Objective measurements for pain including surrogates • Biomarkers, imaging, EEG, function, others… • Composites for pain, multi-dimensional

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