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Objective: Few studies have investigated the relationship between patient experience and diabetes medication adherence among Military Health System (MHS) beneficiaries. We explored the link between patient experience survey ratings and adherence to diabetes medication. The hypothesis was that adherent patients would report better provider-patient experience than non-adherent patients. Methods: Data included 2,599 patient surveys and pharmacy refill records. Adherence was determined using proportion of days covered (PDC) methodology where a patient must have had medications available 80% or more of the time during the observation period. Analysis involved multivariable logistic regression. Results: Medication adherence was 60.2%. Regarding patient experience, those who were with their provider for 5 years or more had greater odds of adherence (OR 1.86[95%CI 1.19, 2.90]) Most of the patients in this study had high morbidity and high care utilization. Patient characteristics that significantly (p<0.05) differentiated adherent versus non-adherent patients were race, mental health status, multiple medication use, glycated hemoglobin (HbA1c) levels, and health utilization. Conclusion: Two key factors of adherence that emerged from this study are that moderate (OR 2.54[95%CI 1.35, 4.75]) and elevated (OR 2.35[95%CI 1.29, 4.30]) HbA1c and patients with 7+ health care providers (OR 1.56[95%CI 1.06,2.29]) had greater odds of adherence. Findings suggest that ability to see provider when needed and provider continuity support adherence to treatment. The practice implications of this study are health practitioners can leverage patient experience and pharmacy data to identify patterns of adherence among patients in the MHS. [ABSTRACT FROM AUTHOR]

SUMMARY: Goal: We examined the relationship of nine hospital environment measures (room cleanliness, room quietness, food temperature, food variety, mattress comfort, room temperature, room privacy, hospital signage, adequate parking) to two patient outcome measures (likelihood of recommending hospital, overall satisfaction with hospital) by type of services received (medical, obstetric, surgical) at all military medical treatment facilities globally. Our aim was to understand the impact of various hospital environment measures on the patient experience. Methods: We analyzed six logistic regression models, one for each patient satisfaction measure and each service line (medical, obstetric, surgical). The patient characteristic variables were gender, patient age group, and beneficiary category (active duty, active duty family member, retiree, retiree dependents). Results are based on 20,534 completed surveys representing inpatient care delivered October 2019 to March 2020. Data are from the Military Health System TRICARE Inpatient Satisfaction Survey, which is based on the Hospital Consumer Assessment of Healthcare Providers and Systems survey with additional Department of Defense questions. Principal Findings: Across all models, nearly all hospital environment measures were found to be significantly related to patient satisfaction outcomes, aside from food variety in two models and room privacy and temperature in one model. The strongest environment impact factor was room cleanliness for both outcomes with odds ratios ranging from 2.1 to 2.7, p <.01 in all cases. The order of impact for the other eight environment factors varied across service lines with some playing dominant roles dependent on the type of care being received. Significant odds ratios (p <.05) ranged from 1.3 to 2.0 for room quietness, 1.5 to 1.9 for hospital signage, 1.3 to 1.5 for both food variety and food temperature, 1.3 to 1.8 for mattress comfort, 1.3 to 1.6 for room temperature, and 1.3 to 1.8 for adequate parking. Hospital environment measures represented a breadth of the patient experience and were significantly related to a patient's overall satisfaction and likelihood to recommend military inpatient facilities. Applications to Practice: Healthcare leaders continuously focus on improving the overall patient experience. Fostering a positive experience includes many factors such as provider and nurse interactions and communications with patients. Moreover, the hospital environment should not be overlooked as also having an impact on patient satisfaction, and hospital leaders—both military and civilian—should continue to emphasize hospital amenities as well. [ABSTRACT FROM AUTHOR]

Background: Spinal cord stimulation (SCS) has been shown to provide pain relief for chronic back and leg pain due to failed back surgery syndrome. But many patients with chronic back pain have not had major back surgery or are not good candidates for surgery, and conventional medical management (CMM) provides limited relief. We have termed this condition nonsurgical refractory back pain (NSRBP). Level 1 evidence does not yet exist showing the therapeutic benefit of SCS for NSRBP. Objective: To compare 10‐kHz SCS plus CMM (10‐kHz SCS + CMM) to CMM alone for treatment of NSRBP in terms of clinical and cost effectiveness. Study Design: Multicenter, randomized controlled trial (RCT), with subjects randomized 1:1 to either 10‐kHz SCS + CMM or CMM alone. Optional crossover occurs at 6 months if treatment does not achieve ≥50% pain relief. Methods: Patients with NSRBP as defined above may be enrolled if they are ineligible for surgery based on surgical consultation. Subjects randomized to 10‐kHz SCS + CMM will receive a permanent implant if sufficient pain relief is achieved in a temporary trial. Both groups will receive CMM per standard of care and will undergo assessments at baseline and at follow‐ups to 12 months. Self‐report outcomes include pain, disability, sleep, mental health, satisfaction, healthcare utilization, and quality of life. Results: Enrollment was initiated on September 10, 2018. Prespecified independent interim analysis at 40% of the enrollment target indicated the sample size was sufficient to show superiority of treatment at the primary endpoint; therefore, enrollment was stopped at 211. Conclusions: This large multicenter RCT will provide valuable evidence to guide clinical decisions in NSRBP. [ABSTRACT FROM AUTHOR]

Purpose: Intractable upper limb and neck pain has traditionally been a challenging pain condition to treat, with conventional spinal cord stimulation (SCS) often inducing positional variation in paraesthesia and/or inadequate coverage of axial neck pain. The purpose of this Australian multi-centre prospective, clinical trial was to assess the safety and effectiveness of paraesthesia-independent 10 kHz SCS for the treatment of upper limb and neck pain. Methods: Subjects with chronic, intractable neck and/or upper limb pain of ≥ 5 cm (on a 0–10-cm visual analogue scale) were enrolled (ACTRN12614000153617) following human research ethics committee approval. Subjects were implanted with two epidural leads spanning C2–C6 vertebral bodies. Subjects with successful trial stimulation were implanted with a Senza® system (Nevro Corp., Redwood City, CA, USA) and included in the safety and effectiveness evaluation at 3 months post-implant (primary endpoint assessment, PEA) and followed to 12 months. Results: Overall, 31/38 (82.6%) subjects reported a successful 10 kHz SCS trial and proceeded to a permanent implant. Twenty-three of 30 subjects (76.7%) met the PEA. Subjects reported a reduction in neck pain and upper limb pain from baseline at the PEA (8.1 ± 0.2 cm vs. 2.9 ± 0.5 cm, 7.3 ± 0.3 cm vs. 2.5 ± 0.5 cm, respectively, p ≤ 0.0001). Disability, as measured by pain disability index score, decreased from 42.6 ± 2.6 at baseline to 22.7 ± 3.2 at PEA. Results were maintained 12 months post-implant. No neurological deficits, nor reports of paraesthesia, were observed. Conclusions: Stable, long-term results demonstrated that 10 kHz SCS is a promising therapy option for intractable chronic upper limb and neck pain. [ABSTRACT FROM AUTHOR]

Introduction: Access to care (ATC) is an important component of providing quality healthcare. Clinics need to be able to accurately measure access; however, patients' reports of access may be different from performance-based data gathered using administrative measures. The purpose of this research is to examine the relationship between ATC administrative data and patient survey results.Materials and Methods: This is a retrospective study performed in military medical treatment facilities. Survey data were obtained from the Joint Outpatient Experience Survey (JOES), and administrative data were collected from the Military Health System Data Repository. The data period was from May 2016 through March 2017 for 135 parent Military Treatment Facilities. This study was approved under the Defense Health Agency Internal Review Board (IRB number: CDO-15-2025). The analyses compare JOES ATC measures to administrative ATC measures. Overall correlation analyses and multivariate regression analyses were performed in order to generate observable correlations between access and healthcare measures (both administrative measures and patient survey items).Results: Results show moderate correlations between the facilities' ATC survey items and administrative measures. These correlations were affected by the composition of the facility patient mix. The patient-based ATC measures from the JOES survey are related to administrative ATC measures collected and monitored by the facilities. In each final regression model, the coefficients for the ATC administrative variables were significant and negative which indicates that as the wait time for an appointment increases, patients' ratings of the time between scheduling and appointment dates declines and patients' assessments of being able to see a provider declines as well.Conclusions: Measuring ATC is a vital step in ensuring the health of patients and the provision of high quality care. Both patient surveys and administrative data are widely used for measuring ATC. This study found statistically significant moderate associations between survey and administrative ATC measures, which remained significant even after controlling for patient characteristics of the facilities. These study results suggest that administrative data can provide an accurate assessment of access; however, survey items can be useful for diagnosing potential issues with access, such as call center scheduling and provider availability. Future studies should explore the gaps in research surrounding best practices at facilities which have high patient experience with access, and look at other survey measures related to access, such as telephone resources and web-based communication programs. [ABSTRACT FROM AUTHOR]

Spinal cord stimulation at 10 kHz is a promising therapy for non-surgical refractory back pain; however, published data are currently limited. We present a subanalysis of prospectively collected clinical outcome data for non-surgical refractory back pain patients treated with 10 kHz spinal cord stimulation, from the independent cohorts of two previous studies (SENZA-RCT and SENZA-EU). Clinical outcomes were evaluated at pre-implantation (baseline), 3 months, 6 months and 12 months following 10 kHz spinal cord stimulator implantation. These included: pain relief; responder rate (≥ 50% pain relief from baseline); remission rate (VAS ≤ 3.0 cm); disability (Oswestry Disability Index(ODI)); and opioid use. At 3 months, average back pain decreased by 70% in the combined cohort (60% in the SENZA-RCT and 78% in the SENZA-EU cohorts). This was sustained at 12 months, with a 73% back pain responder rate and 68% remission rate in the combined cohort. Leg pain relief results were generally comparable to those for back pain relief. At 12 months, the combined cohort had an average decrease in ODI scores of 15.7% points from baseline and opioid use more than halved. In conclusion, 10 kHz spinal cord stimulation reduced pain, disability and opioid consumption in non-surgical refractory back pain subjects. Application of this therapy may improve the care of non-surgical refractory back pain patients and reduce their opioid consumption. [ABSTRACT FROM AUTHOR]

Chronic pain is a common condition that affects the physical, emotional, and mental well‐being of patients and can significantly diminish their quality of life. Due to growing concerns about the substantial risks of long‐term opioid use, both governmental agencies and professional societies have recommended prioritizing the use of nonpharmacologic treatments, when suitable, in order to reduce or eliminate the need for opioid use. The use of 10 kHz spinal cord stimulation (10 kHz SCS) is one such nonpharmacologic alternative for the treatment of chronic, intractable pain of the trunk and limbs. This review examines published clinical data regarding the efficacy of 10 kHz SCS for decreasing chronic pain in patients and its potential to reduce or eliminate opioid usage. Multiple prospective and retrospective studies in patients with intractable pain demonstrated that 10 kHz SCS treatment provided ≥50% pain relief in >70% patients after at least 1 year of treatment. Pain relief with 10 kHz SCS therapy ranged from 54% to 87% in the studies. More importantly, the mean daily dose of opioids required by patients in these studies was reduced after 10 kHz SCS treatment, and on average over 60% patients in studies either reduced or eliminated opioids at the last follow‐up. [ABSTRACT FROM AUTHOR]

Background: Painful diabetic neuropathy (PDN), a debilitating and progressive chronic pain condition that significantly impacts quality of life, is one of the common complications seen with long-standing diabetes mellitus. Neither pharmacological treatments nor low-frequency spinal cord stimulation (SCS) has provided significant and long-term pain relief for patients with PDN. This study aims to document the value of 10-kHz SCS in addition to conventional medical management (CMM) compared with CMM alone in patients with refractory PDN.Methods: In a prospective, multicenter, randomized controlled trial (SENZA-PDN), 216 subjects with PDN will be assigned 1:1 to receive 10-kHz SCS combined with CMM or CMM alone after appropriate institutional review board approvals and followed for 24 months. Key inclusion criteria include (1) symptoms of PDN for at least 12 months, (2) average pain intensity of at least 5 cm-on a 0- to 10-cm visual analog scale (VAS)-in the lower limbs, and (3) an appropriate candidate for SCS. Key exclusion criteria include (1) large or gangrenous ulcers or (2) average pain intensity of at least 3 cm on VAS in the upper limbs or both. Along with pain VAS, neurological assessments, health-related quality of life, sleep quality, and patient satisfaction will be captured. The primary endpoint comparing responder rates (≥50% pain relief) and safety rates between the treatment groups will be assessed at 3 months. Several secondary endpoints will also be reported on.Discussion: Enrollment commenced in 2017 and was completed in 2019. This study will help to determine whether 10-kHz SCS improves clinical outcomes and health-related quality of life and is a cost-effective treatment for PDN that is refractory to CMM.Trial Registration: ClincalTrials.gov identifier: NCT03228420 (registered 24 July 2017). [ABSTRACT FROM AUTHOR]

Discusses ethical principles for researchers who publish and review researches. Ethical standards for the dissemination of research results; Process involved in reviewing grant proposals and proposed journal articles; Conflicts of interest that might be encountered in doing research work.

Discusses ethical problems and principles in human research. Overview of the history of human research; Principles and policies related to human research participants; Definition of voluntary informed consent; Assessment of risks and benefits human research participation.

Objectives: High‐frequency spinal cord stimulation (HF‐SCS) at 10 kHz has proven to be efficacious in the treatment of chronic back and leg pain in a randomized, controlled, trial (SENZA‐RCT). However, large observational studies have yet to be published. Therefore, we performed a real‐world, multicenter, retrospective, review of therapy efficacy in 1660 patients with chronic trunk and/or limb pain. Methods: Data were collected in a real‐world environment and retrospectively sourced from a global database. Included patients were trialed and/or permanently implanted with HF‐SCS at 10 kHz between April 2014 and January 2018. We evaluated responder rates at 3, 6, and 12 months post‐implantation. Response was defined as ≥50% pain relief from baseline. A last visit analysis included responder rate along with overall change in function, sleep, quality of life, and medication intake versus baseline. Results: Eighty‐four percent of our HF‐SCS‐treated patients had both chronic back and leg pain. At least 70% of patients reported response to therapy throughout 12 months of follow‐up. This sustained responder rate was corroborated by the last visit value (74.1%). Most patients reported concomitant improvements in function (72.3%), sleep (68.0%), and quality of life (90.3%) at their last visit versus baseline. Thirty‐two percent of patients reported decreased medication intake at their last visit. Interpretation: Sustained and effective pain relief was experienced by >70% of our HF‐SCS‐treated patients, consistent with the findings of a previously published randomized, controlled, trial. Our review provides complementary evidence to support the treatment of chronic back and leg pain with this therapy. [ABSTRACT FROM AUTHOR]

Background: Current treatments for chronic pain have limited effectiveness and commonly known side effects. Given the prevalence and burden of intractable pain, additional therapeutic approaches are desired. Spinal cord stimulation (SCS) delivered at 10 kHz (as in HF10 therapy) may provide pain relief without the paresthesias typical of traditional low-frequency SCS. The objective of this randomized, parallel-arm, noninferiority study was to compare long-term safety and efficacy of SCS therapies in patients with back and leg pain.Methods: A total of 198 subjects with both back and leg pain were randomized in a 1:1 ratio to a treatment group across 10 comprehensive pain treatment centers. Of these, 171 passed a temporary trial and were implanted with an SCS system. Responders (the primary outcome) were defined as having 50% or greater back pain reduction with no stimulation-related neurological deficit.Results: At 3 months, 84.5% of implanted HF10 therapy subjects were responders for back pain and 83.1% for leg pain, and 43.8% of traditional SCS subjects were responders for back pain and 55.5% for leg pain (P < 0.001 for both back and leg pain comparisons). The relative ratio for responders was 1.9 (95% CI, 1.4 to 2.5) for back pain and 1.5 (95% CI, 1.2 to 1.9) for leg pain. The superiority of HF10 therapy over traditional SCS for leg and back pain was sustained through 12 months (P < 0.001). HF10 therapy subjects did not experience paresthesias.Conclusion: HF10 therapy promises to substantially impact the management of back and leg pain with broad applicability to patients, physicians, and payers. [ABSTRACT FROM AUTHOR]

Objective: Percutaneous neuromodulation therapy (PNT) is a new minimally invasive, office-based treatment for low back pain in which electrical stimulation is delivered to the paraspinal peripheral nerves. The purpose of this study was to determine the safety, tolerability, and clinical efficacy of PNT in a population of patients with subacute low back pain with radiation to the lower extremity. Design: Open label prospective clinical trial. Setting: Multi-center outpatient setting. Participants: We enrolled 83 patients who had radiating low back pain for 4 weeks to 6 months with a pain intensity of at least 4 on a visual analog scale of 0–10. Interventions: Subjects were treated with PNT 1 to 2 times per week for at least 4 weeks. Based on clinical response patients were treated up to an additional 8 weeks. Main Outcome Measures: We recorded baseline visual analog scale (VAS) scores of radiating pain, low back pain, physical activity, and sleep, as well as the Oswestry Disability Questionnaire. Follow-up assessments were performed at each session, and at 5 and 12 weeks. Patients benefiting from treatments at 12 weeks were followed-up at 6 months. Results: Fifty-nine patients completed the study protocol. Mean VAS scores improved as follows: leg/buttock pain decreased by 37% to 4.0 ± 2.6 from a baseline of 6.6 ± 1.7 (P < 0.001); low back pain decreased by 26% to 3.9 ± 2.4 from a baseline of 5.5 ± 2.2 (P < 0.001); activity levels improved by 38% to 3.6 ± 2.2 from a baseline of 6.0 ± 2.2 (P < 0.001); and sleep improved by 27% to 3.1 ± 2.5 from a baseline of 4.8 ± 3.0 (P < 0.001). The Oswestry Low Back Pain Disability scores improved by 24% to 32 ± 16 from a baseline of 43 ± 15 (P < 0.001). Pain relief was sustained over a 3-month observation period. Conclusion: For many patients with subacute radiating low back pain, PNT significantly reduced pain and self-rated disability, and improved sleep quality and... [ABSTRACT FROM AUTHOR]

Importance: Many patients with diabetic peripheral neuropathy experience chronic pain and inadequate relief despite best available medical treatments., Objective: To determine whether 10-kHz spinal cord stimulation (SCS) improves outcomes for patients with refractory painful diabetic neuropathy (PDN)., Design, Setting, and Participants: The prospective, multicenter, open-label SENZA-PDN randomized clinical trial compared conventional medical management (CMM) with 10-kHz SCS plus CMM. Participants with PDN for 1 year or more refractory to gabapentinoids and at least 1 other analgesic class, lower limb pain intensity of 5 cm or more on a 10-cm visual analogue scale (VAS), body mass index (calculated as weight in kilograms divided by height in meters squared) of 45 or less, hemoglobin A1c (HbA1c) of 10% or less, daily morphine equivalents of 120 mg or less, and medically appropriate for the procedure were recruited from clinic patient populations and digital advertising. Participants were enrolled from multiple sites across the US, including academic centers and community pain clinics, between August 2017 and August 2019 with 6-month follow-up and optional crossover at 6 months. Screening 430 patients resulted in 214 who were excluded or declined participation and 216 who were randomized. At 6-month follow-up, 187 patients were evaluated., Interventions: Implanted medical device delivering 10-kHz SCS., Main Outcomes and Measures: The prespecified primary end point was percentage of participants with 50% pain relief or more on VAS without worsening of baseline neurological deficits at 3 months. Secondary end points were tested hierarchically, as prespecified in the analysis plan. Measures included pain VAS, neurological examination, health-related quality of life (EuroQol Five-Dimension questionnaire), and HbA1c over 6 months., Results: Of 216 randomized patients, 136 (63.0%) were male, and the mean (SD) age was 60.8 (10.7) years. Additionally, the median (interquartile range) duration of diabetes and peripheral neuropathy were 10.9 (6.3-16.4) years and 5.6 (3.0-10.1) years, respectively. The primary end point assessed in the intention-to-treat population was met by 5 of 94 patients in the CMM group (5%) and 75 of 95 patients in the 10-kHz SCS plus CMM group (79%; difference, 73.6%; 95% CI, 64.2-83.0; P < .001). Infections requiring device explant occurred in 2 patients in the 10-kHz SCS plus CMM group (2%). For the CMM group, the mean pain VAS score was 7.0 cm (95% CI, 6.7-7.3) at baseline and 6.9 cm (95% CI, 6.5-7.3) at 6 months. For the 10-kHz SCS plus CMM group, the mean pain VAS score was 7.6 cm (95% CI, 7.3-7.9) at baseline and 1.7 cm (95% CI, 1.3-2.1) at 6 months. Investigators observed neurological examination improvements for 3 of 92 patients in the CMM group (3%) and 52 of 84 in the 10-kHz SCS plus CMM group (62%) at 6 months (difference, 58.6%; 95% CI, 47.6-69.6; P < .001)., Conclusions and Relevance: Substantial pain relief and improved health-related quality of life sustained over 6 months demonstrates 10-kHz SCS can safely and effectively treat patients with refractory PDN., Trial Registration: ClincalTrials.gov Identifier: NCT03228420.

Background: Chronic upper extremity pain (UEP) has complex etiologies and is often disabling. It has been shown that 10 kHz SCS can provide paresthesia-free and durable pain relief in multiple pain types and improve the quality of life of patients., Objective: To gain additional evidence on the safety and effectiveness of 10 kHz SCS for the treatment of chronic UEP., Study Design: It was a prospective, multicenter, and observational study. The study was registered on ClinicalTrials.gov prospectively (clinical trial identifier: NCT02703818)., Setting: Multicenter., Patients Intervention and Main Outcomes: A total of 43 subjects with chronic UEP of ≥5 cm (on a 0-10 cm visual analog scale; VAS) underwent a trial of 10 kHz SCS, and subjects with ≥40% pain relief received a permanent implant. All subjects had upper limb pain at baseline, while some had concomitant shoulder or neck pain. Subject outcomes were assessed for 12 months, and the primary outcome was the responder rate (percentage of subjects experiencing ≥50% pain relief from baseline) at three months., Results: Thirty-eight subjects successfully completed the trial (88.3% success rate), 33 received permanent implants (five withdrew consent), and 32 had device activation (per protocol population). There were no paresthesias or uncomfortable changes in stimulation related to changes in posture during the study and there were no neurological deficits. Responder rates at 12 months for upper limb, shoulder, and neck pain in per protocol population (N=32) were 78.1%, 85.2%, and 75.0%, respectively. At 12 months, 84.4% of subjects were satisfied or very satisfied with 10 kHz SCS, and 38.7% either reduced or eliminated opioid usage., Conclusion: This study further supports the effectiveness of 10 kHz SCS for chronic UEP treatment and documents the safety profile of the therapy., Clinical Trial Identifier: NCT02703818., Competing Interests: Dr Kosek received research grants from Boston Scientific and Nevro Corp. Dr Rosen is a consultant to and received research grants from Flowonix, Saluda Medical, Biotronik, Medtronic, and Nevro. Dr Bromberg is a consultant and investor in Nevro and Mudjala. He also reports clinical educator/speakership from Medtronic, outside the submitted work. Dr Gulve is a consultant to Nevro Corp., Saluda Medical and received research grants from Boston Scientific, Abbott, Medtronic, and Mainstay Medical. Dr Esposito is a consultant to Nevro Corp., Abbott, Boston Scientific, Flowonix, and Vertiflex. Dr McRoberts is a consultant to Abbott. Dr Rotte is an employee of Nevro Corp. Mr Gliner was an employee of Nevro Corp. at the time the study was conducted and is now an independent consultant, Seattle, WA, USA. Dr Maneshi was an employee of Nevro Corp. at the time the study was conducted and is now affiliated with Abbott, Sunnyvale, CA, USA. Dr Subbaroyan was an employee of Nevro Corp. at the time the study was conducted and received stock options from Nevro Corp. He is now affiliated with GTX Medical, New York, NY, USA. The authors report no other conflicts of interest in this work., (© 2020 Burgher et al.)

Objective : In the treatment of chronic diseases, remission is commonly used as a meaningful treatment goal, synonymous with the absence of significant clinical signs and symptoms of a disease, but not representing a cure. The objective of this paper is to propose a definition for remission for use as an outcome to evaluate the long-term efficacy of therapies for chronic pain. Methods : Data from a randomized clinical trial (NCT01609972) testing the efficacy of spinal cord stimulation in low back and leg pain subjects was used to evaluate the association between pain and functional outcomes and identify the cut-off value to predict remission. Available data over 24-month assessment period included visual analog score (VAS), disability (Oswestry Disability Index [ODI]), patient and clinician global impression of change (PGIC and CGIC), and patient satisfaction. Cluster analysis, Pearson's correlation coefficients, sensitivity, and specificity analyses were used to evaluate its utility in predicting higher patient functionality and satisfaction. Results : Though the term remission has been used in the chronic pain field, a consistent definition has not been previously established. Based on the analysis of the clinical data, we propose that a sustained (≥6 months) pain score of ≤3.0 cm out of 10 cm on VAS be defined as remission. Applying this definition to the clinical trial data: subjects in remission at 24 months versus non-remitters were significantly more likely to be in the highest functional category of minimally disabled according to the ODI (31.5 vs. 8.2%, respectively, p = 0.001), and be 'very satisfied' (75.7 vs 22.6%, respectively, p < 0.001). Conclusions : The validity of the proposed definition of remission is supported by the persistence of remission in this study group, and its correspondence with patient satisfaction, and reduced disability. Further evaluation of the definition using clinical data from other long-term studies is needed.

Background: Spinal cord stimulation (SCS) has been successfully used to treat chronic intractable pain for over 40 years. Successful clinical application of SCS is presumed to be generally dependent on maximizing paresthesia-pain overlap; critical to achieving this is positioning of the stimulation field at the physiologic midline. Recently, the necessity of paresthesia for achieving effective relief in SCS has been challenged by the introduction of 10 kHz paresthesia-free stimulation. In a large, prospective, randomized controlled pivotal trial, HF10 therapy was demonstrated to be statistically and clinically superior to paresthesia-based SCS in the treatment of severe chronic low back and leg pain. HF10 therapy, unlike traditional paresthesia-based SCS, requires no paresthesia to be experienced by the patient, nor does it require paresthesia mapping at any point during lead implant or post-operative programming., Objectives: To determine if pain relief was related to technical factors of paresthesia, we measured and analyzed the paresthesia responses of patients successfully using HF10 therapy., Study Design: Prospective, multicenter, non-randomized, non-controlled interventional study., Setting: Outpatient pain clinic at 10 centers across the US and Italy., Methods: Patients with both back and leg pain already implanted with an HF10 therapy device for up to 24 months were included in this multicenter study. Patients provided pain scores prior to and after using HF10 therapy. Each patient's most efficacious HF10 therapy stimulation program was temporarily modified to a low frequency (LF; 60 Hz), wide pulse width (~470 mus), paresthesia-generating program. On a human body diagram, patients drew the locations of their chronic intractable pain and, with the modified program activated, all regions where they experienced LF paresthesia. Paresthesia and pain drawings were then analyzed to estimate the correlation of pain relief outcomes to overlap of pain by paresthesia, and the mediolateral distribution of paresthesia (as a surrogate of physiologic midline lead positioning)., Results: A total of 61 patients participated across 11 centers. Twenty-eight men and 33 women with a mean age of 56 ± 12 years of age participated in the study. The average duration of implantable pulse generator (IPG) implant was 19 ± 9 months. The average predominant pain score, as measured on a 0 - 10 visual analog scale (VAS), prior to HF10 therapy was 7.8 ± 1.3 and at time of testing was 2.5 ± 2.1, yielding an average pain relief of 70 ± 24%. For all patients, the mean paresthesia coverage of pain was 21 ± 28%, with 43% of patients having zero paresthesia coverage of pain. Analysis revealed no correlation between percentage of LF paresthesia overlap of predominant pain and HF10 therapy efficacy (P = 0.56). Exact mediolateral positioning of the stimulation electrodes was not found to be a statistically significant predictor of pain relief outcomes., Limitations: Non-randomized/non-controlled study design; short-term evaluation; certain technical factors not investigated., Conclusion: Both paresthesia concordance with pain and precise midline positioning of the stimulation contacts appear to be inconsequential technical factors for successful HF10 therapy application. These results suggest that HF10 therapy is not only paresthesia-free, but may be paresthesia-independent.

Background: Pain relief with spinal cord stimulation (SCS) has focused historically on paresthesias overlapping chronically painful areas. A higher level evidence supports the use of SCS in treating leg pain than supports back pain, as it is difficult to achieve adequate paresthesia coverage, and then pain relief, in the low back region. In comparison, 10-kHz high-frequency (HF10 therapy) SCS therapy does not rely on intraoperative paresthesia mapping and remains paresthesia-free during therapy., Objective: To compare long-term results of HF10 therapy and traditional low-frequency SCS., Methods: A pragmatic randomized, controlled, pivotal trial with 24-month follow-up was conducted across 11 comprehensive pain treatment centers. Subjects had Visual Analog Scale scores of ≥5.0/10.0 cm for both back and leg pain, and were assigned randomly (1:1) to receive HF10 therapy or low-frequency SCS. The primary end point was a responder rate, defined as ≥50% back pain reduction from baseline at 3 months with a secondary end point at 12 months (previously reported). In this article, 24-month secondary results are presented. Non-inferiority was first assessed, and if demonstrated the results were tested for superiority., Results: In the study, 198 subjects were randomized (101 HF10 therapy, 97 traditional SCS). One hundred seventy-one subjects (90 HF10 therapy, 81 traditional SCS) successfully completed a short-term trial and were implanted. Subjects averaged 54.9 ± 12.9 years old, 13.6 ± 11.3 years since diagnosis, 86.6% had back surgery, 88.3% were taking opioid analgesics. At 3 months, 84.5% of implanted HF10 therapy subjects were responders for back pain and 83.1% for leg pain, and 43.8% of traditional SCS subjects were responders for back pain and 55.5% for leg pain (P < .001 for both back and leg pain comparisons, non-inferiority and superiority). At 24 months, more subjects were responders to HF10 therapy than traditional SCS (back pain: 76.5% vs 49.3%; 27.2% difference, 95% CI, 10.1%-41.8%; P < .001 for non-inferiority and superiority; leg pain: 72.9% vs 49.3%; 23.6% difference, 95% CI, 5.9%-38.6%; P < .001 for non-inferiority and P = .003 for superiority). Also at 24 months, back pain decreased to a greater degree with HF10 therapy (66.9% ± 31.8%) than traditional SCS (41.1% ± 36.8%, P < .001 for non-inferiority and superiority). Leg pain also decreased to a greater degree with HF10 therapy (65.1% ± 36.0%) than traditional SCS (46.0% ± 40.4%, P < .001 for non-inferiority and P = .002 for superiority)., Conclusion: This study demonstrates long-term superiority of HF10 therapy compared with traditional SCS in treating both back and leg pain. The advantages of HF10 therapy are anticipated to impact the management of chronic pain patients substantially., Abbreviations: IPG, implantable pulse generatorMCID, minimal clinically important differencePI, permanent implantODI, Oswestry Disability IndexSCS, spinal cord stimulationVAS, Visual Analog Scale.

Few victims of sudden cardiac arrest survive. A new generation of automatic external defibrillators (AEDs), smaller, lighter, easier to use, and less costly, makes the goal of widespread AED deployment and early defibrillation feasible. A low-energy impedance-compensating biphasic waveform allows AED device characteristics more suitable to the goal of early defibrillation than high-energy waveforms. This study observed the performance of such a biphasic waveform in the out-of-hospital setting on 100 consecutive victims of sudden cardiac arrest treated by a wide range of first-responders. AEDs incorporating 150-J impedance-compensating biphasic waveforms were placed into service of 34 EMS systems. Data were obtained from the AED PC data card-recording system. The first endpoint was to determine the effectiveness of this waveform in terminating ventricular fibrillation (VF). The second endpoint was to determine whether or not the use of such an AED culminated in an organized rhythm at the time of patient transfer to an advanced life support (ALS) team or emergency department (ED). The third endpoint was to assess the efficiency of the human-factors design of the AED by measuring user time intervals. The 34 sites provided data from 286 consecutive AED uses, 100 from SCA victims with VF as their initial rhythm upon attachment of the AED. All 286 patients were correctly identified by the AED as requiring a shock (100% sensitivity for the 100 VF patients) or not (100% specificity to the 186 patients not presenting in VF). Times from emergency call to first shock delivery averaged 9.1 +/- 7.3 minutes. A single 150-J biphasic shock defibrillated the initial VF episode in 86% of patients. For all 450 episodes of VF in these 100 patients, an average of 86% +/- 24% of VF episodes were terminated with a single biphasic shock. Of the 449 VF episodes that received up to three shocks, 97% +/- 11% were terminated with three shocks or fewer. The average number of shocks per VF episode was 1.3 +/- 0.7. The average time from AED power-on and pads attached to first defibrillation was 25 +/- 23 sec. At the time of patient transfer, an organized rhythm was present in 65% of the VF patients; asystole was the result in 25%, and VF was in progress in 10%. It is concluded that low-energy impedance-compensating biphasic waveforms terminate long-duration VF at high rates in out-of-hospital cardiac arrest and provide defibrillation rates exceeding those previously achieved with high-energy shocks. Use of this waveform allows AED device characteristics consistent with widespread AED deployment and early defibrillation.