Introduction Lung cancer is the most common cancer in China, with the highest mortality rate. Surgery is the primary treatment for early lung cancer. However, patients with lung cancer have a heavy burden of symptoms within 3 months after surgery, which seriously affects their quality of life (QOL). The symptom management model based on the patient-reported outcome (PRO) is considered the best caregiving model. The clinical evidence about the symptom management of lung cancer within 3 months after the operation is very limited. Herein, we propose a randomized controlled trial to evaluate the PRO score-based monitoring and alert system for follow-up on psychological and physiological symptoms of lung cancer patients within 3 months after surgery and further investigate the effect of intervention measures based on this PRO score-based system. Methods and analysis This multicenter, open-label, randomized, parallel superiority trial will be conducted at four hospitals in China. A total of 440 lung cancer patients will be recruited in this study, who will be randomly assigned to the intervention group or the control group in a ratio of 1:1. Any of the target symptoms reaches the preset threshold (score ≥ 4), the patients will accept the symptom management advices based on the PRO. The patients in the control group will follow the current standard procedure of symptom management. The symptom management system is an electronic management system based on WeChat mini programs. All patients will be evaluated for symptoms through the lung cancer module of the MDASI lung cancer-specific scale on the day before surgery, days 1, 3, 5, and 7 after surgery, and once a week during the 12-week post-discharge period. Simultaneously, the EORTC QLQ-C30 scale will be used to evaluate patients’ quality of life at baseline and the fourth and twelfth week after the surgery. The mean number of symptom threshold events of the intervention and the control groups were compared by t -test, and the changes of PRO were compared by a mixed effect model. The primary endpoint has been set as the 12-week post-discharge period. Discussion This study will test the feasibility of the symptom management system based on the mobile social media applet in postoperative caregiving and the efficacy of psychiatrist-assisted treatment and provide evidence in managing the symptoms of patients in the medium and long term. Trials registration Trials registration number: ChiCTR 2200058876, Registered 18 April 2022
Objective:To investigate the clinical effect of deep brain stimulation (DBS) of the globus pallidus internus (GPi-DBS) for the treatment of primary cervical dystonia.Methods:The clinical data of 14 patients with cervical dystonia treated with GPi-DBS in the Neurosurgery Department of the Second Affiliated Hospital of Air Force Medical University from October 2014 to April 2019 were retrospectively analyzed. The device of DBS was turned on at 1 month after the operation, and all patients were followed up in outpatient clinics at 1, 3, 6 months, 1 year and every year thereafter. Follow-up contents included: observation of hardware-related complications; the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) [including: Torticollis Severity Scale (TSS), Disability Scale (DS) and Pain Scale (PS)] score to assess the improvement of the patient′s symptoms. The calculation formula of improvement rate was: (preoperative score-postoperative score)/preoperative score×100%, of which ≤30% was regarded as mild improvement, >30%-60% as moderate improvement, and >60% was significant improvement.Results:All 14 patients underwent successful operations, and there were no postoperative complications such as intracranial hemorrhage and infection. A total of 28 electrodes were implanted (on 28 sides), of which the monopolar stimulation mode was applied in 13 electrodes, and the double-monopolar (two cathodes) stimulation mode in 15 electrodes. The follow-up time of 14 patients was 33.7±12.4 months (12-53 months) after the DBS device was turned on. During the follow-up period, 2 patients developed dyskinesia in the lower extremities, and the symptoms were improved by adjusting the stimulation parameters. With the extension of follow-up time, TSS, DS and PS scores all showed a decreasing trend (all P<0.001); torticollis symptoms, disability and pain symptoms were significantly improved 3 months after the device was turned on. At the last follow-up, there was no statistically significant difference in the TSS, DS or PS scores compared with the patients′ conditions at 1 year after the device was turned on (all P>0.05). At the last follow-up, the TSS scores of 14 patients were as follows: 1 case was mildly improved, 6 cases were moderately improved, and 7 cases were significantly improved. In the DS score results, 2 cases were mildly improved, 2 cases were moderately improved, and 10 cases were significantly improved. In the PS results, 14 cases were significantly improved. Conclusion:GPi-DBS treatment of primary cervical dystonia has fewer complications, significant improvement in torticollis and pain symptoms, and prolonged effect.
To evaluate the potential effect of radiofrequency ablation and deep brain stimulation in patients with treatment-refractory Tourette syndrome (TS), this study enrolled thirteen patients with TS who were admitted to our hospital between August 2002 and September 2018. Four patients received a single- or multi-target radiofrequency ablation after local, potentiated, or general anesthesia; eight patients underwent deep brain stimulation (DBS) surgery; and one patient underwent both ablation and DBS surgery. The severity of tics and obsessive compulsive disorder symptoms and the quality of life were evaluated using the Yale Global Tic Severity Scale (YGTSS), Yale–Brown Obsessive Compulsive Scale (YBOCS), and Gilles de la Tourette Syndrome Quality of Life scale (GTS-QOL), respectively, before surgery, one month after surgery, and at the final follow-up after surgery, which was conducted in December 2018. A paired-sample t test and a multiple linear regression analysis were performed to analyze the data. All patients underwent the operation successfully without any severe complications. Overall, the YGTSS total scores at one month post-surgery (44.1 ± 22.3) and at the final visit (35.1 ± 23.7) were significantly decreased compared with those at baseline (75.1 ± 6.2; both p < 0.05). Additionally, the YBOCS scores at one month post-surgery (16.5 ± 10.1) and at the final visit (12.0 ± 9.5) were significantly decreased compared with those at baseline (22.5 ± 13.1; both p < 0.05). Furthermore, the GTS-QOL scores at one month post-surgery (44.0 ± 12.8) and at the final visit (31.0 ± 17.8) were significantly decreased compared with those at baseline (58.4 ± 14.2; both p < 0.05). Results from a multiple linear regression analysis revealed that the improvement in the YGTSS total score was independently associated with the improvement in the GTS-QOL score at one month post-surgery (standardized β = 0.716, p = 0.023) and at the final visit (standardized β = 1.064, p = 0.000). Conversely, changes in YBOCS scores did not correlate with changes in GTS-QOL scores (p > 0.05). Our results demonstrate that tics, psychiatric symptoms, and the quality of life in patients with intractable TS may be relieved by stereotactic ablation surgery and deep brain stimulation. Furthermore, it appears that the improvement in tics contributes more to the post-operative quality of life of patients than does the improvement in obsessive compulsive symptoms.
Objective: To evaluate the long-term efficacy of subthalamic nucleus deep brain stimulation (STN-DBS) in the treatment of isolated dystonia, and explore the factors influencing the results. Methods: The clinical data of 23 consecutive patients with isolated dystonia treated with STN-DBS in the Department of Neurosurgery, Tangdu Hospital, Air Force Military Medical University from December 2004 to December 2014,were retrospectively analyzed. Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) was used to quantify the dystonia symptoms and signs. Multiple linear regression analysis was used to explore the influencing factors of the results. Results: The age of the 23 patients including 8 females and 15 males was 19(10, 27) years old. The follow-up time was 5-12 years, with an average of (8.1±1.8) years.Compared with the preoperative period, the BFMDRS movement score decreased by 30.1 [95% confidence interval (CI): 12.3-47.8)] points, 34.7 (95%CI: 17.0-52.4) points, 34.1 (95%CI: 16.4-51.8) points and 34.0 (95%CI: 16.3-51.7) points (all P<0.001) respectively at 1 year, 3 years, 5 years after surgery and the last follow-up, the average improvement rates were (56.0±20.2)%, (65.3±24.0)%, (64.4±25.1)% and (64.3±25.1)%;the disability score decreased by 6.9 (95%CI: 1.4-12.3)points, 8.7 (95%CI: 3.3-14.2)points, 9.0 (95%CI: 3.6-14.5)points, and 9.2 (95%CI: 3.7-14.7) points (all P<0.001), the average improvement rates were (42.9±17.1)%, (55.5±23.2)%, (57.8±24.8)% and (58.7±24.8)%. Patients with DYT1-positive dystonia had higher rates of improvement in movement and disability scores than patients with DYT1-negative, but there was no statistically significant difference. Multiple linear regression analysis showed that gender, age at onset, course of disease, preoperative movement or disability score had no linear relationship with long-term results (improvement rate of movement or disability score) (both P>0.05). Conclusions: STN-DBS is effective and long-lasting in the treatment of isolated dystonia, but no reliable predictor has been found.
OBJECTIVE: To evaluate the clinical effect of the position of stimulation contacts relative to the hyperdirect pathway (HDP) on the alleviation of motor symptoms in patients with Parkinson disease (PD). METHODS: A group of 11 patients diagnosed with idiopathic PD were included in this study, and all selected targets were in the subthalamic nucleus (STN). In 1 patient, a single side electrode was implanted because of unilateral symptoms; in all other patients, bilateral electrodes each containing 4 discrete contacts were implanted. Nine contacts were excluded due to adverse reactions caused by stimulation, and thus a total of 75 active contacts were evaluated using the same stimulus parameters. Fiber tractography results were individually processed using StealthViz software before all data were subjected to statistical analysis. RESULTS: Under the same stimulus parameters, the shortest distance of each contact to the HDP was smaller in group I (n = 45; >50% improvement rate) compared with group II (n = 30; <= 50% improvement rate) (mean, 1.18 +/- 0.86 mm vs. 2.14 +/- 1.20 mm; t = 3.78; P < 0.05), and the shortest distance had a negative correlation with the improvement of motor symptoms (r = L0.48; P < 0.05). CONCLUSIONS: Stimulation of the HDP coincided with the improvement of motor symptoms in patients with PD. We propose an improvement of the direct visualization method based on diffusion tensor imaging fiber tractography of the HDP to select the motor part of the STN. Further rigorous clinical trials are needed to verify the value of this method for achieving precise target location and individualized treatment.