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Background: Epilepsy and other seizure disorders account for a high disease burden in Germany. As a timely diagnosis and accurate treatment are crucial, improving the management of these disorders is important. Outside of Germany, outpatient long-term video EEGs (ALVEEGs) have demonstrated the potential to support the diagnosis and management of epilepsy and other seizure disorders. This study aims to evaluate the implementation of ALVEEGs as a new diagnostic pathway in eastern parts of Germany to diagnose epilepsy and other seizure disorders and to assess if ALVEEGs are equally effective as the current inpatient-monitoring gold standard, which is currently only available at a limited number of specialized centers in Germany. Methods: ALVEEG is a prospective, multicenter, randomized controlled equivalence trial, involving five epilepsy centers in the eastern states of Germany. Patients will be randomized into either intervention (IG) or control group (CG), using a permuted block randomization. The sample size targeted is 688 patients, continuously recruited over the trial. The IG will complete an ALVEEG in a home setting, including getting access to a smartphone app to document seizure activity. The CG will receive care as usual, i.e., inpatient long-term video-EEG monitoring. The primary outcome is the proportion of clinical questions being solved in the IG compared to the CG. Secondary outcomes include hospital stays, time until video EEG, time until diagnosis and result discussion, patients' health status, quality of life and health competence, and number and form of epilepsy-related events and epileptiform activity. Alongside the trial, a process implementation and health economic evaluation will be conducted. Discussion: The extensive evaluation of this study, including an implementation and health economic evaluation, will provide valuable information for health policy decision-makers to optimize future delivery of neurological care to patients affected by epilepsy and other seizure disorders and on the uptake of ALVEEG into standard care in Germany. Trial registration: German Clinical Trials Register (DRKS00032220), date registered: December 11, 2023. [ABSTRACT FROM AUTHOR]

Background: Hyperuricemia (HU) remains a priority research area in every medical science, including complementary and alternative medicine interventions and homeopathy; however, the research evidence is limited. In homeopathy, Thlaspi bursa pastoris (TBP) is considered to be a potential treatment option in HU. Methods: An open-label, randomized, equivalence trial was conducted comparing TBP with individualized homeopathic medicines (IHMs). Serum uric acid (SUA) was the primary outcome; Gout Assessment Questionnaire version 2.0 (GAQ-2) and Measure Yourself Medical Outcome Profile version 2.0 (MYMOP-2) were the secondary outcomes; all measured at baseline and after 6 and 12 weeks. Intention-to-treat analysis was carried out to detect noninferiority and group differences using unpaired t-tests and two-way repeated-measure analysis of variance (ANOVA). Results: There were no differences between the groups at baseline. Reduction in SUA after 6 and 12 weeks was similar between groups (P = 0.784). Group differences in the secondary outcomes were also nonsignificant (all P > 0.05). TBP revealed noninferiority against IHMs, both after 6 weeks and 12 weeks in SUA and MYMOP-2 profile scores, but not in GAQ2 scores. Sulfur and Calcarea carbonica were the most frequently prescribed medicines in the IHMs group. There were no harms or serious adverse events reported from either of the groups. Conclusion: TBP acted noninferior to IHM in HU and both appeared to be equally effective. Rigorous and larger trials are warranted. Trial Registration: This trial was registered in the Clinical Trials Registry – India (CTRI/2018/10/016174; UTN: U1111-1221-8000).

Background From previous studies, the frequency of administration of recombinant human erythropoietin injection (rHuEPO) has no association with its therapeutic effect in renal anemia in chronic kidney disease (CKD), and there is no significant difference in the efficacy between weekly single dosing and divided dosing. Most hemodialysis patients are clinically treated with moderate-dose rHuEPO, but there is a lack of research on the safety of single and divided administration of moderate-dose rHuEPO. Objective To compare the safety between weekly single and divided administration of moderate-dose rHuEPO for renal anemia in maintenance hemodialysis patients. Methods This study was designed as a randomized, parallel-group controlled, non-inferiority clinical trial. Eighty-eight patients with renal anemia who underwent maintenance hemodialysis at the Hemodialysis Room, Tongzhou Branch, Dongzhimen Hospital, Beijing University of Chinese Medicine from January 2019 to May 2021 were selected and randomly divided into an experimental group and a control group with 44 in each. For comparing the safety and efficacy of weekly single and divided administration of moderate-dose rHuEPO, 29 cases (experimental subgroup 1) and other 15 cases (experimental subgroup 2) in the experimental group received an rHuEPO dose of 6 000 U, and an rHuEPO dose of 4 000 U, once a week, respectively; 30 cases (control subgroup 1) in the control group received a single rHuEPO dose of 2 000 U, three times a week (6 000 U per week in total), and other 14 cases (control subgroup 2) received a single rHuEPO dose of 2 000 U, twice a week (4 000 U per week in total) . Results Safety analysis: two-factor repeated-measures ANOVA showed that the type of intervention scheme and duration had no interaction effects on systolic blood pressure, diastolic blood pressure, mean arterial pressure, and pre-dialysis serum potassium between experimental subgroup 1 and control subgroup 1, and between experimental subgroup 2 and control subgroup 2 (P>0.05), and produced no main effects on systolic blood pressure, diastolic blood pressure, mean arterial pressure, and pre-dialysis serum potassium in experimental subgroup 1 and control subgroup 1, and between experimental subgroup 2 and control subgroup 2 (P>0.05). The serum levels of AST, ALT and TBiL were similar between experimental subgroup 1 and control subgroup 1 at baseline and 12 weeks of treatment (P>0.05). Likewise, they were similar between experimental subgroup 2 and control subgroup 2 at baseline and 12 weeks of treatment (P>0.05). No thromboembolic, cardiovascular or cerebrovascular events and gastrointestinal reactions related to rHuEPO occurred in any of the subgroups during the 12-week treatment. Efficacy analysis: the hemoglobin level (reference range was 110-130 g/L) in experimental subgroup 1 〔65.5% (19/29) 〕was similar to that in control subgroup 1 〔73.3% (22/30) 〕at 12 weeks of treatment (χ2=0.425, P=0.514). The serum levels of hemoglobin were similar between experimental subgroup 2 and control subgroup 2 at 12 weeks of treatment (P>0.05). The levels of red blood cell count, hematocrit, percentage and absolute number of reticulocytes, ferritin and transferrin saturation did not vary between experimental subgroup 1 and control subgroup 1, and between experimental subgroup 2 and control subgroup 2 either at baseline or 12 weeks of treatment (P>0.05) . Conclusion Weekly single and divided administration of moderate-dose erythropoietin had no significant difference in medication safety in the treatment of renal anemia in maintenance hemodialysis patients.

Obstructive sleep apnea (OSA) is a high prevalent chronic disease that may lead to many complications, and cause great potential harm to health. Epidemiological studies have showed that OSA is closely related to the development of various cardiovascular diseases. There are about 66 million patients with moderate to severe OSA in China, but 80% of potential OSA patients have not been diagnosed and treated in time. OSA is mainly diagnosed and treated in a hospital-based sleep center currently, as the process is time-consuming and laborious, which may be lead to a delay in diagnosis and treatment of many patients. Supported by the development of Internet of Things, Internet technologies and other emerging technologies, remote medicine has been increasingly used in the diagnosis and management of chronic diseases owing to its advantages of easy access, interactivity, high efficiency, resource sharing, service continuity and without space-time constraints. Our center has initially built a management system for remote diagnosis and treatment of OSA, but its clinical efficacy and economic value need to be further verified. We designed a randomized controlled trial protocol to assess whether the clinical benefits of the low-cost remote healthcare model are similar to those of the traditional healthcare model by comparing them in terms of clinical efficacy and health economic benefits, hoping to provide a reference for the efficient use of medical resources and further promotion of remote diagnosis and treatment of chronic diseases.

Abstract Background Tic disorders (TD) is a neuropsychiatric disease with twitch as the main manifestation in childhood. Jiu-Wei-Xi-Feng granules has been marketed in China for treating children with TD. As Long Gu (Os Draconis) in the composition of this Chinese patent medicine is a rare and expensive medicinal material protected by the Chinese government, therefore, we consider replacing it with Mu Li (Concha Ostreae) that has the same effect and is cheaper. This study is designed to evaluate the clinical equivalence between Jiu-Wei-Xi-Feng granules (Os Draconis replaced by Concha Ostreae) (JWXFD) and Jiu-Wei-Xi-Feng granules (original formula) (JWXFO) in children with TD (consumption of renal yin and liver wind stirring up internally syndrome). Methods/design This is a multicenter, randomized, double-blind, equivalence trial comparing the efficacy and safety of JWXFD and JWXFO in treating Children with tic disorders (consumption of renal yin and liver wind stirring up internally syndrome). A total of 288 patients will be recruited and randomly assigned to two groups in a 1:1 ratio. The treatment course is 6 weeks, with a 2 weeks follow-up. The primary outcome is the mean change value from baseline to 6th week by the Yale Global Tic Severity Scale total tic score (YGTSS-TTS). Secondary outcomes include total effective rate of tic, Yale Global Tic Severity Scale (YGTSS) scores and its factor scores (the degree of motor tics, phonic tics and social function damage), Clinical Global Impression-Severity scale, and TCM syndrome efficacy. Discussion The design of this study refers to a large number of similar research design points, and asked for opinions of peer experts, and finally reached a consensus. This trial will provide high-quality evidence on the clinical equivalence between JWXFD and JWXFO and provide a basis for the marketing of JWXFD. Trial registration ChiCTR2000032312 Registered on 25 April 2020, http://www.chictr.org.cn/showproj.aspx?proj=52630

Background: Using traditional patient-reported outcomes (PROs), such as paper-based questionnaires, is cumbersome in the era of web-based medical consultation and telemedicine. Electronic PROs may reduce the burden on patients if implemented widely. Considering promising reports of DryEyeRhythm, our in-house mHealth smartphone app for investigating dry eye disease (DED) and the electronic and paper-based Ocular Surface Disease Index (OSDI) should be evaluated and compared to determine their equivalency. Objective: The purpose of this study is to assess the equivalence between smartphone app–based and paper-based questionnaires for DED. Methods: This prospective, nonblinded, randomized crossover study enrolled 34 participants between April 2022 and June 2022 at a university hospital in Japan. The participants were allocated randomly into 2 groups in a 1:1 ratio. The paper-app group initially responded to the paper-based Japanese version of the OSDI (J-OSDI), followed by the app-based J-OSDI. The app-paper group responded to similar questionnaires but in reverse order. We performed an equivalence test based on minimal clinically important differences to assess the equivalence of the J-OSDI total scores between the 2 platforms (paper-based vs app-based). A 95% CI of the mean difference between the J-OSDI total scores within the ±7.0 range between the 2 platforms indicated equivalence. The internal consistency and agreement of the app-based J-OSDI were assessed with Cronbach α coefficients and intraclass correlation coefficient values. Results: A total of 33 participants were included in this study. The total scores for the app- and paper-based J-OSDI indicated satisfactory equivalence per our study definition (mean difference 1.8, 95% CI –1.4 to 5.0). Moreover, the app-based J-OSDI total score demonstrated good internal consistency and agreement (Cronbach α=.958; intraclass correlation=0.919; 95% CI 0.842 to 0.959) and was significantly correlated with its paper-based counterpart (Pearson correlation=0.932, P <.001). Conclusions: This study demonstrated the equivalence of PROs between the app- and paper-based J-OSDI. Implementing the app-based J-OSDI in various scenarios, including telehealth, may have implications for the early diagnosis of DED and longitudinal monitoring of PROs. [ABSTRACT FROM AUTHOR]

Background: Tic disorders (TD) is a neuropsychiatric disease with twitch as the main manifestation in childhood. Jiu-Wei-Xi-Feng granules has been marketed in China for treating children with TD. As Long Gu (Os Draconis) in the composition of this Chinese patent medicine is a rare and expensive medicinal material protected by the Chinese government, therefore, we consider replacing it with Mu Li (Concha Ostreae) that has the same effect and is cheaper. This study is designed to evaluate the clinical equivalence between Jiu-Wei-Xi-Feng granules (Os Draconis replaced by Concha Ostreae) (JWXFD) and Jiu-Wei-Xi-Feng granules (original formula) (JWXFO) in children with TD (consumption of renal yin and liver wind stirring up internally syndrome).Methods/design: This is a multicenter, randomized, double-blind, equivalence trial comparing the efficacy and safety of JWXFD and JWXFO in treating Children with tic disorders (consumption of renal yin and liver wind stirring up internally syndrome). A total of 288 patients will be recruited and randomly assigned to two groups in a 1:1 ratio. The treatment course is 6 weeks, with a 2 weeks follow-up. The primary outcome is the mean change value from baseline to 6th week by the Yale Global Tic Severity Scale total tic score (YGTSS-TTS). Secondary outcomes include total effective rate of tic, Yale Global Tic Severity Scale (YGTSS) scores and its factor scores (the degree of motor tics, phonic tics and social function damage), Clinical Global Impression-Severity scale, and TCM syndrome efficacy.Discussion: The design of this study refers to a large number of similar research design points, and asked for opinions of peer experts, and finally reached a consensus. This trial will provide high-quality evidence on the clinical equivalence between JWXFD and JWXFO and provide a basis for the marketing of JWXFD.Trial Registration: ChiCTR2000032312 Registered on 25 April 2020, http://www.chictr.org.cn/showproj.aspx?proj=52630. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to verify the equivalence and effectiveness of the tablet-administered Korean Repeatable Battery for the Assessment of Neuropsychological Status (K-RBANS) for the prevention and early detection of dementia. Methods: Data from 88 psychiatry and neurology patient samples were examined to evaluate the equivalence between tablet and paper administrations of the K-RBANS using a non-randomly equivalent group design. We calculated the prediction scores of the tablet-administered K-RBANS based on demographics and covariate-test scores for focal tests using norm samples and tested format effects. In addition, we compared the receiver operating characteristic curves to confirm the effectiveness of the K-RBANS for preventing and detecting dementia. Results: In the analysis of raw scores, line orientation showed a significant difference (t=-2.94, p<0.001), and subtests showed small to large effect sizes (0.04-0.86) between paper- and tablet-administered K-RBANS. To investigate the format effect, we compared the predicted scaled scores of the tablet sample to the scaled scores of the norm sample. Consequently, a small effect size (d≤0.20) was observed in most of the subtests, except word list and story recall, which showed a medium effect size (d=0.21), while picture naming and subtests of delayed memory showed significant differences in the one-sample t-test. In addition, the area under the curve of the total scale index (TSI) (0.827; 95% confidence interval, 0.738-0.916) was higher than that of the five indices, ranging from 0.688 to 0.820. The sensitivity and specificity of TSI were 80% and 76%, respectively. Conclusion: The overall results of this study suggest that the tablet-administered K-RBANS showed significant equivalence to the norm sample, although some subtests showed format effects, and it may be used as a valid tool for the brief screening of patients with neuropsychological disorders in Korea. [ABSTRACT FROM AUTHOR]

This study is to investigate the effectiveness and safety of bloodletting puncture (BP) for acute ischemic stroke (AIS) when used in combination with standard treatment, as well as the patients' feelings and attitudes toward the treatment. This is a mixed method research which includes a multi-center, superiority, randomized controlled clinical trial, and focus group interview. A total of 360 AIS participants will be enrolled. They will be randomized into one of the following two groups for 7 d: (a) BP with standard treatment group ( n = 180); (b) standard treatment group ( n = 180). The primary outcome will be National Institute of Health stroke scale (NIHSS) score at day 7 after treatment. Secondary outcomes will be changes of Glasgow Coma Scale score, NIHSS score, mRS and Traditional Chinese Medicine syndrome score from baseline to 7, 14, and 30 d after treatment, recurrence rate and all-cause mortality rate within 30 d, and the safety assessments. The focus group will be conducted with a purposive sample of 1-2 acupuncturists and 1-2 patients respectively at each center at 7 and 30 d after treatment. We designed a mixed method study to evaluate the effect of BP, an acupuncture therapy for patients with AIS. If the findings of this study confirm the effectiveness of BP to reduce the NIHSS score and other related outcomes and patients are willing to accept the therapy, we believe this study will help the implementation of this therapy in clinical practice, and provide new evidence for the treatment of AIS.