Objective: To evaluate whether ankle-foot orthosis (AFO) has a beneficial effect on dorsiflexion angle increase during the swing phase among individuals with stroke and patient-important outcomes in individuals with stroke. Literature Survey: Randomized controlled trials (RCTs), randomized crossover trials, and cluster RCTs until May 2020 were researched through CEN-TRAL, MEDLINE, EMBASE, PEDro, CINAHL, and REHABDATA databases. Studies reporting on AFO use to improve walking, functional mobility, quality of life, and activity limitations and reports of adverse events in individuals with stroke were included. Methodology: Two independent reviewers extracted the data and assessed the risk of bias. The certainty of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluations approach. Synthesis: Fourteen trials that enrolled 282 individuals with stroke and compared AFO with no AFO were included. Compared with no AFO, AFO could increase the dorsiflexion angle of ankle joints during walking (mean difference [MD, 3.7 ]; 95% confidence interval [CI], 2.0-5.3; low certainty of evidence). Furthermore, AFO could improve walking ability (walking speed) (MD, 0.09 [m/s]; 95% CI, 0.06-0.12; low certainty of evidence). No study had reported the effects of AFO on quality of life, adverse events, fall frequency, and activities of daily life. Conclusions: Our findings suggest that AFO improved ankle kinematics and walking ability in the short term; nonetheless, the evidence was characterized by a low degree of certainty.
Objective: We compared the accuracy of formulas for predicting ADL outcome constructed by multiple regression analysis in post-stroke patients admitted to a Kaifukuki rehabilitation ward. Methods: We divided 1,502 post-stroke patients into a construction group used to generate prediction formulas, and a validation group used to confirm the prediction accuracy. Prediction formula S was constructed by conventional multiple regression analysis using Functional Independence Measuremotor score (mFIM) at discharge as the dependent variable. Prediction formula R was constructed by reciprocal multiple regression analysis. Prediction equation E was constructed by calculating mFIM at discharge via mFIM effectiveness. In the validation group, predicted mFIM at discharge was calculated, and intraclass correlation coefficient and absolute value of residual were compared. Results: Intraclass correlation coefficients were 0.86 using prediction formula S, 0.90 using prediction formula R, and 0.89 using prediction formula E. Absolute values of residual were 9.38±6.62 using prediction formula S, 7.30±6.56 using prediction formula R, and 7.56±6.45 using prediction formula E. The Steel-Dwass test detected a significant difference between prediction formulas S and R, and between prediction formulas S and E (both p<0.05). Conclusion:The prediction accuracy of formulas for predicting ADL outcome constructed by multiple regression analysis is improved by adding a transformation that brings the model toward linearity.
PURPOSE This systematic review aimed to investigate the efficacy of telemedicine (TM) using videoconferencing systems in outpatient care for patients with cancer. METHODS We searched six electronic databases (CENTRAL, MEDLINE, EMBASE, CINAHL, ICTRP, and ClinicalTrials.gov) through June 2021 to identify randomized controlled trials that evaluated the use of TM using videoconferencing systems compared with usual face-to-face care in outpatient care for patients with cancer. We assessed the certainty of evidence on the basis of the Grading of Recommendations, Assessment, Development, and Evaluation. RESULTS From the 2,400 articles screened, six randomized controlled trials were eligible for this study. Two studies evaluated the use of TM in cancer follow-up and four investigated psychotherapy for cancer. TM using videoconferencing systems may result in no differences in primary outcomes such as patient satisfaction (standardized mean difference, 0.11; 95% CI, –0.18 to 0.40) and outpatient attendance complete proportion (risk difference, 0.02%; 95% CI, –0.04 to 0.09), and secondary outcomes such as medical professional satisfaction, time devoted to outpatient care, and depression score. The certainty of evidence for these outcomes was low. Although the average money spent on outpatient visit was a primary outcome, the level of evidence was uncertain. CONCLUSION Our results suggest that TM using videoconferencing systems in outpatient care for patients with cancer may be as effective as usual face-to-face care. Use of TM more frequently may be considered for patients with cancer who are expected to obtain benefit from TM using videoconference systems.
Introduction In the US phase 2 RESCUE trial, ziltivekimab, a fully human monoclonal antibody against the ligand of the pro-inflammatory cytokine interleukin-6, was shown to reduce biomarkers of inflammation in patients with chronic kidney disease (CKD) and elevated levels of high-sensitivity C-reactive protein (hsCRP), a marker of inflammation and cardiac risk.1 Here, we present outcomes from the phase 2 RESCUE-2 trial of ziltivekimab in a patient population from Japan. Purpose To evaluate the efficacy and safety of ziltivekimab 15 mg and 30 mg compared with placebo in Japanese patients with non-dialysis-dependent CKD (NDD-CKD). Methods We conducted a randomized, double-blind, placebo-controlled trial in 36 patients aged ≥20 years with stage 3–5 NDD-CKD and hsCRP ≥2 mg/L. Patients were randomly assigned to receive subcutaneous ziltivekimab 15 mg (n=11) or 30 mg (n=12), or placebo (n=13) at weeks 0, 4 and 8. The primary endpoint was percentage change in hsCRP levels from baseline to end of treatment (EOT) (average of week 10 and week 12 values); secondary endpoints included percentage change from baseline to EOT in levels of fibrinogen, serum amyloid A (SAA), N-terminal pro B-type natriuretic peptide (NT-proBNP) and lipids. Analysis of endpoints was performed using Wilcoxon two-sample test; differences between treatment groups were calculated using the Hodges–Lehmann estimator. Results Baseline characteristics are shown in the Table. At EOT, median hsCRP levels were reduced by 96% and 93% in the ziltivekimab 15 mg and 30 mg groups, respectively, compared with 27% for placebo (both p<0.001 vs placebo). At both doses, ziltivekimab provided rapid and sustained suppression of hsCRP over the 12-week treatment period (Figure). Statistically significant reductions in levels of the inflammatory markers SAA (15 mg: 71%; 30 mg: 58%; placebo: 30%; both p<0.01 vs placebo) and fibrinogen (38%; 34%; 2%; both p<0.0001 vs placebo) were also observed. Ziltivekimab was well tolerated, did not result in persistent neutropenia or thrombocytopenia, and had minimal effect on liver enzyme levels. There was a non-significant increase in low-density lipoprotein levels and a neutral effect on high-density lipoprotein levels. There was a limited, but statistically significant (p<0.05 vs placebo) increase in triglycerides, whereby levels increased in some patients and decreased in others. Conclusion Ziltivekimab effectively reduced inflammatory biomarkers associated with atherosclerosis in patients from Japan with CKD and residual inflammatory risk as measured by hsCRP. A significant reduction of more than 90% in hsCRP levels for both doses of ziltivekimab was demonstrated, with a safety profile similar to placebo. Overall, the results of the RESCUE-2 trial in Japan are consistent with the efficacy and safety results of the US-based RESCUE trial. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): This study was funded by Novo Nordisk A/S. Medical writing support was provided by Johanna Scheinost PhD, PharmaGenesis Oxford Central, Oxford, UK, with funding from Novo Nordisk A/S.
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