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BackgroundStroke is a very time-sensitive pathology, and many new solutions target the optimization of prehospital stroke care to improve the stroke management process. In-ambulance telemedicine, defined by live bidirectional audio-video between a patient and a neurologist in a moving ambulance and the automated transfer of vital parameters, is a promising new approach to speed up and improve the quality of acute stroke care. Currently, no evidence exists on the cost effectiveness of in-ambulance telemedicine. ObjectiveWe aim to develop a first cost effectiveness model for in-ambulance telemedicine and use this model to estimate the time savings needed before in-ambulance telemedicine becomes cost effective. MethodsCurrent standard stroke care is compared with current standard stroke care supplemented with in-ambulance telemedicine using a cost-utility model measuring costs and quality-adjusted life-years (QALYs) from a health care perspective. We combine a decision tree with a Markov model. Data from the UZ Brussel Stroke Registry (2282 stroke patients) and linked hospital claims data at individual level are combined with literature data to populate the model. A 2-way sensitivity analysis varying both implementation costs and time gain is performed to map the different cost-effective combinations and identify the time gain needed for cost effectiveness and dominance. For several modeled time gains, the cost-effectiveness acceptability curve is calculated and mapped in 1 figure. ResultsUnder the base-case scenario (implementation cost of US $159,425) and taking a lifetime horizon into account, in-ambulance telemedicine is a cost-effective strategy compared to standard stroke care alone starting from a time gain of 6 minutes. After 12 minutes, in-ambulance telemedicine becomes dominant, and this results in a mean decrease of costs by US –$30 (95% CI –$32 to –$29) per patient with 0.00456 (95% CI 0.00448 to 0.00463) QALYs on average gained per patient. In over 82% of all probabilistic simulations, in-ambulance telemedicine remains under the cost-effectiveness threshold of US $47,747. ConclusionsOur model suggests that in-ambulance telemedicine can be cost effective starting from a time gain of 6 minutes and becomes a dominant strategy after approximately 15 minutes. This indicates that in-ambulance telemedicine has the potential to become a cost-effective intervention assuming time gains in clinical implementations are realized in the future.

Introduction: In the search for objective measures of therapeutic outcomes for patients with spinal cord stimulation (SCS) devices, various metrics of cardiac performance have been linked to pain as well as overall health. To track such measures at home, recent studies have incorporated wearables to monitor cardiac activity over months or years. The drawbacks to wearables, such as patient compliance, would be obviated by on-device sensing that incorporates the SCS lead. This study sought to evaluate the feasibility of using SCS leads to record cardiac electrograms. Methods: The quality of signals sensed by externalized, percutaneous leads in the thoracic spine of 10 subjects at the end of their SCS trial were characterized across various electrode configurations and postures by detecting R-peaks and calculating signal-to-noise ratio (SNR). In a subset of 5 subjects, cardiac metrics were then compared to those measured simultaneously with a wearable. Results: The average signal quality was acceptable for R-peak detection (i.e., SNR > 5) for all configurations and positions across all 10 subjects, with higher signal quality achieved when recording in resting positions. Notably, the spinal lead recordings enabled more reliable beat detection compared to the wearable (n = 29 recording pairs; p < 0.001). When excluding wearable recordings with over 35% missed beats, the inter-beat intervals across devices were highly correlated (n = 22 recording pairs; Pearson correlation: R = 0.99, p < 0.001). Further comparisons in these aligned wearable and corresponding spinal-lead recordings revealed significant differences in the frequency domain metrics (i.e., absolute and normalized high and low frequency HRV power, p < 0.05), but not in time domain HRV parameters. Discussion: The ability of an implanted SCS system to record electrocardiograms, as demonstrated here, could provide the basis of automated SCS therapy by tracking potential biomarkers of the patient's overall health state without the need for additional external devices. [ABSTRACT FROM AUTHOR]

Background: Spinal Cord Stimulation (SCS) may provide pain relief in patients with therapy-refractory Persistent Spinal Pain Syndrome Type II (PSPS-T2). Despite the evidence that SCS can reduce disability and reduce pain medication usage, only 25% of the patients is able to completely omit pain medication usage after 12 months of SCS. To tackle the high burden of patients who consume a lot of pain medication, tapering programs could be initiated before starting a trajectory with SCS. The current objective is to examine whether a pain medication tapering program before SCS alters disability in PSPS-T2 patients compared to no tapering program. Methods and design: A three-arm, parallel-group multicenter randomized controlled trial will be conducted including 195 patients who will be randomized (1:1:1) to either (a) a standardized pain medication tapering program, (b) a personalized pain medication tapering program, or (c) no tapering program before SCS implantation, all with a follow-up period until 12 months after implantation. The primary outcome is disability. The secondary outcomes are pain intensity, health-related quality of life, participation, domains affected by substance use, anxiety and depression, medication usage, psychological constructs, sleep, symptoms of central sensitization, and healthcare expenditure. Discussion: Within the PIANISSIMO project we propose a way to reduce the risks of adverse events, medication-induced hyperalgesia, tolerance, and dependence by providing pain medication tapering before SCS. Due to the lack of a commonly accepted in-hospital tapering approach, two different tapering programs will be evaluated in this study. If pain medication tapering programs are deemed to be more effective than no tapering on disability, this would add to the evidence towards an improved patient-centered care model in this patient group and set a clear path to advocate for pain medication tapering before SCS as the new standard treatment guideline for these patients. Trial registration: ClinicalTrials.gov NCT05861609. Registered on May 17, 2023. [ABSTRACT FROM AUTHOR]

Introduction: Spinal cord stimulation is a common treatment option for neuropathic pain conditions. Despite its extensive use and multiple technological evolutions, long term efficacy of spinal cord stimulation is debated. Most studies on spinal cord stimulation include a rather limited number of patients and/or follow-ups over a limited period. Therefore, there is an urgent need for real-world, long-term data. Methods: In 2018, the Belgian government initiated a nationwide secure platform for the follow-up of all new and existing spinal cord stimulation therapies. This is a unique approach used worldwide. Four years after the start of centralized recording, the first global extraction of data was performed. Results: Herein, we present the findings, detailing the different steps in the centralized procedure, as well as the observed patient and treatment characteristics. Furthermore, we identified dropouts during the screening process, the reasons behind discontinuation, and the evolution of key indicators during the trial period. In addition, we obtained the first insights into the evolution of the clinical impact of permanent implants on the overall functioning and quality of life of patients in the long-term. Discussion: Although these findings are the results of the first data extraction, some interesting conclusions can be drawn. The long-term outcomes of neuromodulation are complex and subject to many variables. Future data extraction will allow us to identify these confounding factors and the early predictors of success. In addition, we will propose further optimization of the current process. [ABSTRACT FROM AUTHOR]

Background/importance Concerns have been raised that effects observed in studies of spinal cord stimulation (SCS) funded by industry have not been replicated in non-industry-funded studies and that findings may differ based on geographical location where the study was conducted. Objective To investigate the impact of industry funding and geographical location on pain intensity, function, health-related quality of life and adverse events reported in randomized controlled trials (RCTs) of SCS. Evidence review Systematic review conducted using MEDLINE, CENTRAL, EMBASE and WikiStim databases until September 2022. Parallel-group RCTs evaluating SCS for patients with neuropathic pain were included. Results of studies were combined in random-effects meta-analysis using the genericinverse variance method. Subgroup meta-analyses were conducted according to funding source and study location. Risk of bias was assessed using Cochrane RoB 2.0 tool. Findings Twenty-nine reports of 17 RCTs (1823 participants) were included. For the comparison of SCS with usual care, test for subgroup differences indicate no significant differences (p=0.48, moderate certainty evidence) in pain intensity score at 6 months for studies with no funding or funding not disclosed (pooled mean difference (MD) -1.96 (95% CI -3.23 to -0.69; 95% prediction interval (PI) not estimable, I²=0%, τ²=0)), industry funding (pooled MD -2.70 (95% CI -4.29 to -1.11; 95% PI -8.75 to 3.35, I²=97%, τ²=2.96) or non-industry funding (MD -3.09 (95% CI -4.47 to -1.72); 95% PI, I² and τ² not applicable). Studies with industry funding for the comparison of high-frequency SCS (HF-SCS) with low-frequency SCS (LF-SCS) showed statistically significant advantages for HF-SCS compared to LF-SCS while studies with no funding showed no differences between HF-SCS and LF-SCS (low certainty evidence). Conclusion All outcomes of SCS versus usual care were not significantly different between studies funded by industry and those independent from industry. Pain intensity score and change in pain intensity from baseline for comparisons of HF-SCS to LF-SCS seem to be impacted by industry funding. [ABSTRACT FROM AUTHOR]