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 PARTICIPANTSThe 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 A 1c (HbA 1c ) 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 MEASURESThe 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 HbA 1c over 6 months. RESULTSOf 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 s...

Unrecognized anxiety is a difficult clinical presentation in cardiology. Anxiety leads to recurring emergency department visits and the need for numerous diagnostic evaluations to rule out cardiovascular disease (CVD). This review focuses broadly on anxiety and its subtypes in relation to the onset and progression of CVD while describing helpful guidelines to better identify and treat anxiety. Potential mechanisms of cardiopathogenesis are also described. An emerging literature demonstrates that anxiety disorders increase the risk for incident CVD but a causal relationship has not been demonstrated. Anxiety portends adverse prognosis in persons with established CVD that is independent from depression. The level of clinical priority received by depression should be extended to research and clinical intervention efforts in anxiety. Anxiety holds direct relevance for uncovering mechanisms of cardiopathogenesis, developing novel therapeutic strategies, and initiating clinical interventions in the population at risk of developing heart disease, or those already diagnosed with CVD.

The transition from urban centres back to rural and remote communities can be challenging for rural cancer survivors after treatment. This study aimed to (a) provide deeper understanding of the experiences of rural survivors who have completed active cancer treatment and returned to their rural communities, and (b) determine strategies to re-orient existing services or develop new interventions to more appropriately meet rural survivors’ service preferences and needs. Semi-structured interviews were conducted with 22 adults (64% female) who lived outside of a metropolitan area and had completed active cancer treatment (n = 13), were the carer for a rural/remote cancer survivor (n = 6), or were both a survivor and carer (n = 3). Thematic analysis was conducted to identify dominant themes in the qualitative data. A range of physical, psychological and practical challenges that impact quality of life among rural survivors post-treatment were found. These challenges appeared to be compounded by a lack of trust in local rural healthcare services and a lack of clear post-treatment pathways to quality of life-enhancing support services. Acceptable strategies to overcome barriers included nurse-led, telephone-based, or face-to-face interventions, initiated and continued by the same service provider, and that included support to manage emotional challenges associated with post-treatment survivorship. The findings will inform the design of interventions to better meet rural cancer survivors’ post-treatment support needs.