RESUMO
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.
RESUMO
Introduction: Mobile health diagnostics have demonstrated effectiveness in detecting and managing chronic diseases. This method comparison study aims to assess the accuracy and precision of the previously evaluated OptiBP™ technology over a four-week study period. This device uses optical signals recorded by placing a patient's fingertip on a smartphone's camera to estimate blood pressure (BP). Methods: In adult participants without cardiac arrhythmias and minimal interarm blood pressure difference (systolic arterial pressure (SAP) < 15 mmHg or diastolic arterial pressure (DAP) < 10 mmHg), three pairs of 30 s BP measurements with the OptiBP™ (test method) were simultaneously compared using three pairs of measurements with the non-invasive oscillometric brachial cuff (reference method) on the opposite arm over a period of four consecutive weeks at a rate of two measurements per week (one in the morning and one in the afternoon). The agreement of BP values between the two technologies was analyzed using Bland-Altman and error grid analyses. The performance of the smartphone application was investigated using the International Organization for Standardization (ISO) definitions, which require the bias ± standard deviation (SD) between two technologies to be lower than 5 ± 8 mmHg. Results: Among the 65 eligible volunteers, 53 participants had adequate OptiBP™ BP values. In 12 patients, no OptiBP™ BP could be measured due to inadequate signals. Only nine participants had known chronic arterial hypertension and 76% of those patients were treated. The mean bias ± SD between both technologies was -1.4 mmHg ± 10.1 mmHg for systolic arterial pressure (SAP), 0.2 mmHg ± 6.5 mmHg for diastolic arterial pressure (DAP) and -0.5 mmHg ± 6.9 mmHg for mean arterial pressure (MAP). Error grid analyses indicated that 100% of the pairs of BP measurements were located in zones A (no risk) and B (low risk). Conclusions: In a cohort of volunteers, we observed an acceptable agreement between BP values obtained with the OptiBPTM and those obtained with the reference method over a four-week period. The OptiBPTM fulfills the ISO standards for MAP and DAP (but not SAP). The error grid analyses showed that 100% measurements were located in risk zones A and B. Despite the need for some technological improvements, this application may become an important tool to measure BP in the future.