Analysis of Adverse Effects of Cryoneurolysis for the Treatment of Spasticity.

OBJECTIVE: The aim of the study is to report adverse effects from clinical studies on ultrasound-guided percutaneous cryoneurolysis for spasticity. DESIGN: Patients were prospectively enrolled in three studies at a single institution. Cryoneurolysis was performed to primarily motor nerve branches (medial and lateral pectoral, musculocutaneous, radial, median, ulnar, tibial, obturator) and mixed motor sensory nerve trunks (median, ulnar, suprascapular, radial, and tibial). RESULTS: Cryoneurolysis was performed for 277 nerves (99 mixed motor sensory), on 113 patients (59 F, 54 M, average age 54.4 yrs). One patient had a local skin infection and two patients had bruising or swelling; all resolved within 1 mo. Nine reported nerve pain or dysesthesia (two motor, seven mixed motor sensory nerves). Four received no treatment, four oral or topical medications, two perineural injections, one botulinum toxin. Three patients' symptoms remained until 3 mos and one had numbness at six. One patient had botulinum toxin injections for cramping. All had at minimum 3-mo follow-up; seven withdrew (x̄ = 5.4 mos), four passed away. None of these 11 reported adverse effects. CONCLUSIONS: A total of 96.75% of nerve treatments had no pain or dysesthesias beyond treatment. Few had pain or numbness beyond 3 mos. Cryoneurolysis has potential to be a safe spasticity treatment with manageable adverse effects.

Comparing patient-reported outcomes across countries: An assessment of methodological challenges.

OBJECTIVES: There is little published literature on the comparison of patient-reported outcomes between countries. This study aimed to assess pre- and postoperative health among samples of patients undergoing elective groin hernia repair procedures in the National Health Service (NHS), England, and groin hernia patients in Vancouver, Canada. METHODS: We used datasets from two different sources. For the English NHS we used published anonymized patient-level data files which include the EQ-5D(3L) patient-reported outcome measure and a number of demographic and clinical characteristics. For Vancouver, we used data from a sample of Vancouver patients who completed the same instrument during a similar time frame. English patients were matched with Vancouver participant's characteristics using propensity score methods. A linear regression model was used to measure differences in postoperative visual analogue scale values between countries, adjusting for patient characteristics. RESULTS: Our study revealed a range of methodological issues concerning the comparability of patient-reported outcomes following hernia repair surgery in the two health systems. These related to differences in approaches to collecting patient-reported outcome measures and the nature of explanatory variables (self-report vs. administrative data), among other challenges. As a consequence, there were differences between the matched samples and the NHS data, indicating a healthy participant bias. Unadjusted results found that Vancouver patients (N = 280) reported more problems in domains of mobility, self care, usual activities and anxiety/depression than the matched cohort of NHS patients (N = 840). Interpreting differences is challenging given different sampling designs. CONCLUSIONS: There are significant hurdles facing comparisons of surgical patients' outcomes between countries, including adjusting for patient differences, health system factors and approaches to survey administration. While between-country comparisons of surgical outcomes using patient-reported outcomes shows significant promise, much work on standardizing sampling design, variables and analytic methods is needed.

Health and Quality of Life Outcomes Among Patients Undergoing Surgery for End-Stage Ankle Arthritis.

BACKGROUND: There is little research investigating which aspects of health-related quality of life change following ankle arthrodesis and total ankle replacement surgery. The objective of this study was to report on statistically and clinically relevant changes in multiple dimensions of health-related quality of life among patients undergoing ankle replacement or fusion surgery. METHODS: This study was based on a prospective sample of ankle arthrodesis and total ankle replacement patients. Participants complete the Ankle Osteoarthritis Scale, EuroQoL's EQ-5D-3L, the Patient Health Questionnaire-9, and the pain intensity, interference with enjoyment of life, and general activity pain instrument. Instruments were completed preoperatively and postoperatively. Multivariate regression models were used to measure the change in health-related quality of life outcomes, adjusting for demographic, clinical, and health service utilization. RESULTS: Participants achieved statistically significant improvements in health-related quality of life in each domain of measurement. The majority of participants reported clinically significant improvement in pain. Mild depressive symptoms were common, and clinically significant improvement in depression symptoms occurred in 22% of patients. Gains in health were more pronounced among participants reporting the worst preoperative health in all domains quality of life measured. CONCLUSIONS: Pain showed a clinically important improvement among 64% of participants whereas 22% reported a clinically meaningful improvement in their depression symptoms postoperatively. Clinically significant gains in health-related quality of life were not experienced by all participants in all dimensions. Further research is warranted to better understand the failure of some patients to improve in dimensions of health studied. LEVEL OF EVIDENCE: Level III, comparative study.