Objective
To identify variables that influence pain reduction following peripheral nerve field stimulation (PNFS) in order to identify a potential responder profile.
Methods
Exploratory univariate and multivariate (random forest) analyses were performed separately on 2 randomized controlled trials and a registry; all included patients with chronic back pain, mainly failed back surgery syndrome. An international expert panel judged the clinical relevance of variables to identify responders by consensus.
Results
Variables identified that may help predict PNFS success in patients with back pain include patient and pain characteristics (age, time since onset of pain and spinal surgery, pain medication history, position and size of pain area, pain severity, mixed nociceptive/neuropathic pain, health‐related quality of life, depression, functional disability, and leg pain status), implant procedure variables (the number and position of leads, paresthesia coverage, and amount of pain relief during the trial), and programming (number of programs, cathodes, and anodes; pulse rate; pulse width; and percentage of device usage).
Conclusions
While these analyses are exploratory and restricted to a limited sample size, they suggest variables that may play a role in predicting a therapeutic response. These results, however, are informative only and should be cautiously interpreted. Future research to validate the variables in a clinical study is needed.
Context: Patient-reported outcome measures(PROMs) have been endorsed for providing patient-centered care. However, PROMs must represent their target populations.
Objective: Identify the primary concerns of collegiate-athletes experiencing injury and compare those to the content of established PROMs.
Design: Cross-Sectional
Setting: Collegiate athletic training facilities
Patients or Other Participants: Collegiate athletes experiencing injury(n=149).
Main Outcome Measures: Open-ended response to the Measure Yourself Medical Outcome Profile(MYMOP-2) were used to identify primary concerns, which were linked to International Classification of Functioning, Disability and Health(ICF) taxonomy codes. Items of the Patient-Reported Outcomes Measurement Information System(PROMIS®), modified Disablement of the Physically Active Scale(mDPAS), Lower Extremity Functional Scale(LEFS), Knee injury and Osteoarthritis Outcome Score(KOOS), International Knee Documentation Committee Subjective Knee Form(IKDC), the Foot and Ankle Ability Measure (FAAM), Disablement of the Arm, Shoulder, and Hand(DASH), Functional Arm Scale for Throwers(FAST), and Kerlan-Jobe Orthopaedic Clinic questionnaire(KJOC) were linked to ICF codes. Chi-square single-sample goodness-of-fit tests examined if 70% of content was shared between PROM and participant-generated codes.
Results: Participant-generated concerns were primarily related to sport-participation(16%) and pain(23%). Chi-square tests showed that the LEFS and FAAM presented significant content differences with common participant-generated lower extremity responses at all levels. The PROMIS®, DASH, mDPAS, KOOS, IKDC, FAST, and KJOC did not have significant content differences for level 2 codes; however, significant differences were present for level 3 analyses except for the KOOS and IKDC.(p<0.001). All measures except the IKDC contained significant superfluous content(p<0.05).
Conclusions: The presence of significant content differences supports clinician perceived barriers regarding relevance of established PROMs. However, the IKDC was observed to be a relevant and efficient PROM for evaluating the primary concerns of collegiate-athletes experiencing lower extremity injury. Clinicians should consider utilizing patient-generated measures to support coverage of patient-specific concerns in care.
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