scholarly journals Use of telemedicine for follow-up of lupus nephritis in the COVID-19 outbreak: the 6-month results of a randomized controlled trial

2021 ◽  
Author(s):  
Ho SO ◽  
Evelyn CHOW ◽  
Isaac T CHENG ◽  
Sze-Lok LAU ◽  
Tena K LI ◽  
...  
Keyword(s):  
Patient Satisfaction ◽  
Lupus Nephritis ◽  
Disease Control ◽  
Controlled Trial ◽  
Controlled Study ◽  
Physician Global Assessment ◽  
Short Term ◽  
Patient Satisfaction Score ◽  
Randomized Controlled

Abstract Objective To evaluate the short-term patient satisfaction, compliance, disease control and infection risk of telemedicine (TM) compared with standard in-person follow-up (FU) for patients with lupus nephritis (LN) during COVID-19.Methods This was a single-center open-label randomized controlled study. Consecutive patients followed at the LN clinic were randomized to either TM or standard FU (SF) group in a 1:1 ratio. Patients in the TM group received FU via videoconferencing. SF group patients continued conventional in-person outpatient care. The 6-month data were compared and presented.Results From June to December 2020, 122 patients were randomized (TM: 60, SF: 62) and had at least 2 FUs. There were no baseline differences, including SLEDAI-2k and proportion of patients in lupus low disease activity state (LLDAS), between the 2 groups except a higher physician global assessment score (PGA) in the TM group. After a mean FU of 19.8 ± 4.5 weeks, the overall patient satisfaction score was higher in the TM group. More patients in the TM group had hospitalization (15/60, 25.0% vs 7/62, 11.3%; p = 0.049) with higher baseline PGA (OR = 1.15, 95% CI 1.07–1.23) being the independent predictor. The proportions of patients remained in LLDAS were similar in the 2 groups (TM: 75.0% vs SF: 74.2%, p = 0.919). None of the patients had COVID-19.Conclusion TM FU resulted in better patient satisfaction and similar short-term disease control in patients with LN compared to standard care. However, it was associated with more hospitalizations and might need to be complemented by in-person visits especially in patients with higher PGA.

scholarly journals Endothelial Dysfunction, Atherosclerosis, and Increase of von Willebrand Factor and Factor VIII: A Randomized Controlled Trial in Swine

2021 ◽  
Author(s):  
Ferdows Atiq ◽  
Jens van de Wouw ◽  
Oana Sorop ◽  
Ilkka Heinonen ◽  
Moniek P. M. de Maat ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Randomized Controlled Trial ◽  
Endothelial Dysfunction ◽  
Controlled Trial ◽  
Short Term ◽  
Randomized Controlled ◽  
Von Willebrand ◽  
Willebrand Factor

AbstractIt is well known that high von Willebrand factor (VWF) and factor VIII (FVIII) levels are associated with an increased risk of cardiovascular disease. It is still debated whether VWF and FVIII are biomarkers of endothelial dysfunction and atherosclerosis or whether they have a direct causative role. Therefore, we aimed to unravel the pathophysiological pathways of increased VWF and FVIII levels associated with cardiovascular risk factors. First, we performed a randomized controlled trial in 34 Göttingen miniswine. Diabetes mellitus (DM) was induced with streptozotocin and hypercholesterolemia (HC) via a high-fat diet in 18 swine (DM + HC), while 16 healthy swine served as controls. After 5 months of follow-up, FVIII activity (FVIII:C) was significantly higher in DM + HC swine (5.85 IU/mL [5.00–6.81]) compared with controls (4.57 [3.76–5.40], p = 0.010), whereas VWF antigen (VWF:Ag) was similar (respectively 0.34 IU/mL [0.28–0.39] vs. 0.34 [0.31–0.38], p = 0.644). DM + HC swine had no endothelial dysfunction or atherosclerosis during this short-term follow-up. Subsequently, we performed a long-term (15 months) longitudinal cohort study in 10 Landrace–Yorkshire swine, in five of which HC and in five combined DM + HC were induced. VWF:Ag was higher at 15 months compared with 9 months in HC (0.37 [0.32–0.42] vs. 0.27 [0.23–0.40], p = 0.042) and DM + HC (0.33 [0.32–0.37] vs. 0.25 [0.24–0.33], p = 0.042). Both long-term groups had endothelial dysfunction compared with controls and atherosclerosis after 15 months. In conclusion, short-term hyperglycemia and dyslipidemia increase FVIII, independent of VWF. Long-term DM and HC increase VWF via endothelial dysfunction and atherosclerosis. Therefore, VWF seems to be a biomarker for advanced cardiovascular disease.

scholarly journals Transconjunctival versus Transcutaneous Injection of Botulinum Toxin into the Lacrimal Gland to Reduce Lacrimal Production: A Randomized Controlled Trial

Toxins ◽  
2021 ◽  
Vol 13 (2) ◽  
pp. 77
Author(s):  
Andrew G. Lee ◽  
Shin-Hyo Lee ◽  
Minsu Jang ◽  
Sang Jae Lee ◽  
Hyun Jin Shin
Keyword(s):  
Botulinum Toxin ◽  
Lacrimal Gland ◽  
Botulinum Toxin A ◽  
Controlled Trial ◽  
Clinical Effectiveness ◽  
Controlled Study ◽  
Randomized Controlled ◽  
Delivery Routes ◽  
Tear Meniscus Height

The purpose of this study was to determine and compare the effects between injecting botulinum toxin A (BTX-A) transconjunctivally into the palpebral lobe and transcutaneously into the orbital lobe of the lacrimal gland in patients with epiphora due to lacrimal outflow obstruction. This randomized controlled study included 53 eyes of 31 patients with unilateral or bilateral epiphora. Patients were randomly allocated to receive an injection of BTX-A (3 units) either transconjunctivally (n = 15, 25 eyes) or transcutaneously (n = 16, 28 eyes). For objective assessments, the tear meniscus height and Schirmer’s I test with topical anesthesia were measured at baseline and after 2, 6, 12, and 24 weeks of follow-up. Subjective evaluations were performed using the Munk score. After BTX-A injection, patients in both groups experienced significant objective and subjective reductions in tearing at all follow-up times compared to pre-injection (success rate 86.8%), and the effect lasted for a mean duration of 5.63 months. The two delivery routes showed similar clinical effectiveness for a single injected dose of BTX-A. In conclusion, injecting BTX-A via either a transconjunctival or transcutaneous route helps to reduce normal tear production and results in significant improvements in the symptoms in patients with epiphora.

Short-term acenocumarine (A) or dalteparine (D) for the prevention of central venous catheter-related thrombosis (CVCrT) in cancer patients. A randomized controlled study based on serial venographies

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 8549-8549 ◽  
Author(s):  
M. De Cicco ◽  
M. Matovic ◽  
R. Pacenzia ◽  
D. Fantin ◽  
M. Caserta ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Controlled Trial ◽  
Venous Catheter ◽  
Median Number ◽  
Controlled Study ◽  
Thrombosis Prophylaxis ◽  
Short Term ◽  
Chi Square ◽  
Randomized Controlled ◽  
Chi Square Test

8549 Background: Timing and frequency of non occlusive (nO) or occlusive (O) CVCrT in cancer patients (pts) remain unclear. In this randomized controlled trial we studied these points and evaluated the efficacy and safety of short-term prophylaxis with A or D in the prevention of CVCrT. Methods: Consecutive cancer pts without contraindications to short-term anticoagulation, scheduled for chemotherapy via CVC, were randomly assigned to receive: A 1 mg/day for 3 days before and 8 days after CVC insertion; D 5,000 IU 2 hours before and daily for 8 days after CVC insertion; no anticoagulant treatment (NT). All pts underwent venography (V) at day 8 and 30 after CVC insertion and then every two months until CVC removal . The primary endpoint was V detected CVCrT, evaluated as nO or O when it was partially or completely occlusive of the vein lumen, respectively. Bleeding episodes were recorded. Proportions were compared using chi-square test together with odds ratio (OR). Results: 450 pts were randomized, 348 of whom (120/150 A, 114/150 D, and 114/150 NT) underwent V (median number of procedures 4, range 2–8). Both A and D reduced the frequency of V detected CVCrT (21.9% A vs 55.3% NT, OR= 4.35 (95% CI 2.43–7.69), p<0.001; 40% D vs 55.3% NT, OR= 1.85 (95% CI 1.10–3.13), p=0.02). A was more effective than D (OR= 2.37 (CI 1.34–4.22), p= 0.003). The frequency of O CVCrT was not different in the 3 groups (0.9% A, 5.0% D, 4.4% NT; p= 0.18). Overall, 5.1% of pts with CVCrT were symptomatic, all presenting O CVCrT (42% of pts with O CVCrT were not symptomatic). Most CVCrTs (95.6%) were observed at day 8 after CVC insertion. No major bleeding or pulmonary embolism occurred. Conclusions: In this study, acenocumarine was more effective than dalteparine in reducing V detected CVCrT. The doses of prophylactic agents used in this study proved to be safe. Symptomatic CVCrT evaluation alone underestimates the actual CVCrT frequency. The first days following CVC insertion are at highest risk for CVCrT. Short term thrombosis prophylaxis appears to be superior to no treatment without the expenses and inconveniences inherent in long-term prophylaxis. No significant financial relationships to disclose.

scholarly journals An Integrative Neuro-Psychotherapy Treatment to Foster the Adjustment in Acquired Brain Injury Patients—A Randomized Controlled Study

2020 ◽  
Vol 9 (6) ◽  
pp. 1684
Author(s):  
Antoine Urech ◽  
Tobias Krieger ◽  
Eveline Frischknecht ◽  
Franziska Stalder-Lüthy ◽  
Martin grosse Holtforth ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Brain Injury ◽  
Brain Injuries ◽  
Controlled Trial ◽  
Acquired Brain Injury ◽  
Post Treatment ◽  
Controlled Study ◽  
Randomized Controlled ◽  
Treatment Standard

Adjustment disorders (AjD) with depressive symptoms following an acquired brain injury (ABI) is a common phenomenon. Although brain injuries are increasing more and more, research on psychological therapies is comparably scarce. The present study compared, by means of a randomized controlled trial (RCT), a newly developed integrative treatment (Standard PLUS) to a standard neuropsychological treatment (Standard). Primary outcomes were depressive symptoms assessed with the Beck Depression Inventory (BDI-II) at post-treatment and 6-month follow-up assessment. In total, 25 patients (80% after a stroke) were randomized to one of the two conditions. Intention-to-treat analyses showed that the two groups did not significantly differ either at post-treatment nor at follow-up assessment regarding depressive symptoms. Both treatments showed large within-group effect sizes on depressive symptoms. Regarding secondary outcomes, patients in the Standard PLUS condition reported more emotion regulation skills at post-assessment than in the control condition. However, this difference was not present anymore at follow-up assessment. Both treatments showed medium to large within-group effects sizes on most measures for patients suffering from an AjD after ABI. More research with larger samples is needed to investigate who profits from which intervention.

scholarly journals Autologous Matrix-Induced Chondrogenesis (AMIC) and AMIC Enhanced by Autologous Concentrated Bone Marrow Aspirate (BMAC) Allow for Stable Clinical and Functional Improvements at up to 9 Years Follow-Up: Results from a Randomized Controlled Study

2019 ◽  
Vol 8 (3) ◽  
pp. 392 ◽  
Author(s):  
Laura de Girolamo ◽  
Herbert Schönhuber ◽  
Marco Viganò ◽  
Corrado Bait ◽  
Alessandro Quaglia ◽  
...  
Keyword(s):  
Bone Marrow ◽  
Bone Marrow Aspirate ◽  
Controlled Trial ◽  
Activity Level ◽  
Controlled Study ◽  
Level Of Evidence ◽  
Chondral Lesions ◽  
Randomized Controlled ◽  
Functional Scores

The aims of the study were to evaluate long-term outcomes after autologous matrix-induced chondrogenesis (AMIC) in the treatment of focal chondral lesions and to assess the possible improvements given by the combination of this technique with bone marrow aspirate concentrate (BMAC). Twenty-four patients (age range 18–55 years) affected by focal knee chondral lesions were treated with standard AMIC or AMIC enhanced by BMAC (AMIC+). Pain (Visual Analogue Scale (VAS)) and functional scores (Lysholm, International Knee Documentation Committee (IKDC), Tegner, Knee injury and Osteoarthritis Outcome Score (KOOS)) were collected pre-operatively and then at 6, 12, 24, 60, and 100 months after treatment. Magnetic resonance imaging (MRI) evaluation was performed pre-operatively and at 6, 12, and 24 months follow-ups. Patients treated with AMIC+ showed higher Lysholm scores (p = 0.015) and lower VAS (p = 0.011) in comparison with patients in the standard AMIC group at the 12 months follow-up. Both treatments allowed for functional and pain improvements with respect to pre-operative levels lasting up to 100 months. MRI revealed consistent cartilage repair at 24 months in both groups. This study shows that AMIC and AMIC+ are effective treatments for focal chondral lesions with beneficial effect lasting up to 9 years. AMIC+ allows for faster recovery from injury, and is thus more indicated for patients requiring a prompt return to activity. Level of evidence: II, randomized controlled trial in an explorative cohort.

scholarly journals Short-term effects of enhanced treatment for depression in primary care: results from a randomized controlled trial

2005 ◽  
Vol 36 (1) ◽  
pp. 15-26 ◽  
Author(s):  
A. SMIT ◽  
H. KLUITER ◽  
H. J. CONRADI ◽  
K. VAN DER MEER ◽  
B. G. TIEMENS ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Treatment Modalities ◽  
Psychiatric Evaluation ◽  
Patient Acceptance ◽  
Short Term ◽  
Psychiatric Interview ◽  
Randomized Controlled

Background. Depression is a highly prevalent, often recurring or persistent disorder. The majority of patients are initially seen and treated in primary care. Effective treatments are available, but possibilities for providing adequate follow-up care are often limited in this setting. This study assesses the effectiveness of primary-care-based enhanced treatment modalities on short-term patient outcomes.Method. In a randomized controlled trial we evaluated a psycho-educational self-management intervention. We included 267 adult patients meeting criteria for a DSM-IV diagnosis of major depressive disorder, assessed by a structured psychiatric interview. Patients were randomly assigned to: the Depression Recurrence Prevention (DRP) program (n=112); a combination of the DRP program with psychiatric consultation (PC+DRP, n=39); a combination with brief cognitive behavior therapy (CBT+DRP, n=44); and care as usual (CAU, n=72). Follow-up assessments were made at 3 months (response 90%) and 6 months (85%).Results. Patient acceptance of enhanced care was good. The mean duration of the index episode was 11 weeks (S.D.=9·78) and similar in CAU and enhanced care. Recovery rate after 6 months was 67% overall; 17% of all participants remained depressed for the entire 6-month period.Conclusion. Enhanced care did not result in better short-term outcomes. We found no evidence that the DRP program was more effective than CAU and no indications for added beneficial effects of either the psychiatric evaluation or the CBT treatment to the basic format of the DRP program. Observed depression treatment rates in CAU were high.

scholarly journals Percutaneous Epidural Adhesiolysis Using Inflatable Balloon Catheter and Balloon-less Catheter in Central Lumbar Spinal Stenosis with Neurogenic Claudication: A Randomized Controlled Trial

2018 ◽  
Vol 1 (21;1) ◽  
pp. 593-605
Author(s):  
Seong-Soo Choi
Keyword(s):  
Spinal Stenosis ◽  
Lumbar Spinal Stenosis ◽  
Controlled Trial ◽  
Balloon Catheter ◽  
Controlled Study ◽  
Neurogenic Claudication ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Lumbar Spinal

Background: When conventional interventional procedures fail, percutaneous epidural adhesiolysis (PEA), which has moderate evidence for successful treatment of lumbar spinal stenosis (LSS), has been recommended over surgical treatments. In a previous study, we demonstrated the efficacy of a newly developed inflatable balloon catheter for overcoming the access limitations of pre-existing catheters for patients with severe stenosis or adhesions. Objectives: This study compared the treatment response of combined PEA with balloon decompression and PEA only in patients with central LSS over 6 months of follow-up. Study Design: This study used a randomized, single-blinded, active-controlled trial design. Setting: This study took place in a single-center, academic, outpatient interventional pain management clinic. Methods: This randomized controlled study included 60 patients with refractory central LSS who suffered from chronic lower back pain and/or lumbar radicular pain. Patients failed to maintain improvement for > 1 month with epidural steroid injection or PEA using a balloon-less catheter. Patients were randomly assigned to one of 2 interventions: balloon-less (n = 30) and inflatable balloon catheter (n = 30). The Numeric Rating Scale (NRS-11), Oswestry Disability Index (ODI), Global Perceived Effect of Satisfaction (GPES), and Medication Quantification Scale III were each measured at 1, 3, and 6 months after PEA. Results: There was a significant difference between groups in NRS-11 reduction ≥ 50% (or 4 points), ODI reduction ≥ 30% (or 10 points), GPES ≥ 6 and ≥ 4 points at 6 months, and NRS11 reduction ≥ 50% (or 4 points) at 3 months after PEA (P < .03). The proportion of successful responders was higher in the balloon group than in the balloon-less group throughout the total follow-up period. Furthermore, there was a statistically significant difference between groups at 6 months after PEA (P = .035). Limitations: The results may vary according to the definition of successful response. Follow-up loss in the present study seemed to be high. Conclusion: PEA using the inflatable balloon catheter leads to significant pain reduction and functional improvement compared to PEA using the balloon-less catheter in patients with central LSS. The study protocol was approved by our institutional review board (2012-0235), and written informed consent was obtained from all patients. The trial was registered with the Clinical Research Information Service (KCT 0002093). Key words: Balloon decompression, central, chronic pain, epidural adhesiolysis, lumbar, percutaneous, radiculopathy, spinal stenosis

scholarly journals Impact of Testing on Sexually Transmitted Infections among Female Brothel Sex Workers in Bangladesh: A Randomized Controlled Trial

2021 ◽  
Author(s):  
Asad Islam ◽  
HongQi Alexis Tan ◽  
Claire C. Bristow ◽  
Md Golam Hasnain ◽  
Russell Smyth ◽  
...  
Keyword(s):  
Sexually Transmitted Infections ◽  
Sex Workers ◽  
Controlled Trial ◽  
Intervention Group ◽  
Controlled Study ◽  
Baseline Survey ◽  
Control Group ◽  
Sexually Transmitted ◽  
Randomized Controlled

Past studies that have designed interventions to reduce the prevalence of sexually transmitted infections (STIs) have typically provided onsite treatment to sex workers who tested positive, which were expensive and difficult to implement. The purpose of this study was to examine the effect of an intervention which tested for STIs and provided information on the closest treatment facility on reducing the prevalence of STIs among female brothel-based sex workers (BSWs) in Bangladesh. The study adopted a pre–post interventional design as well as a randomized controlled study design. A baseline sample and follow-up urine sample were collected to evaluate the prevalence of STIs among participants in the treatment, but not control group. A baseline survey and interviews were also conducted for both the groups. The study found a nonsignificant reduction from baseline to follow-up in STI prevalence among intervention participants (adjusted odds ratio [aOR]: 0.74; 95% CI: 0.38, 1.45). However, the participants in the intervention group were significantly more likely to have a repeat client (aOR: 1.60; 95% CI: 1.12, 2.29) and nonsignificantly less likely to engage with a client suspected of having an STI (aOR: 0.62; 95% CI: 0.39, 1.00) than participants in the control group. The intervention testing of STIs and providing information to the positive cases about nearest treatment facilities were not effective in reducing the prevalence of STIs among BSWs. Further study of the clinical and behavioral impacts of such efforts to reduce STIs among BSWs is warranted.

Sign in / Sign up

Export Citation Format

Share Document