scholarly journals Stem Cell, Fibrin Glue, and Normal Saline on Partially Torn Tendons: A Randomized Controlled Trial

2021 ◽  
Author(s):  
Se-Woong Chun ◽  
Won Kim ◽  
Sang Yoon Lee ◽  
Chai-Young Lim ◽  
Keewon Kim ◽  
...  
Keyword(s):  
Stem Cell ◽  
Fibrin Glue ◽  
Normal Saline ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Supraspinatus Tendon ◽  
Safety Measures ◽  
Randomized Controlled ◽  
Partial Tears ◽  
Stem Cell Injection

Abstract Background: Tendons have limited reparative ability and perform a relatively simple mechanical function via the extracellular matrix. Thus, the injured tendon might successfully treated by stem cell transplantation. We performed a randomized, controlled study to investigate the effects of mesenchymal stem cell injection for treating partial tears in the supraspinatus tendon.Methods: We enrolled 24 patients with shoulder pain lasting more than 3 months and partial tears in the supraspinatus tendon. Participants were assigned to three groups: stem cells in fibrin glue, normal saline/fibrin glue mixture, and normal saline only, with which intra-lesional injection was performed. Pain at activity and rest, shoulder function and tear size were evaluated. For safety measures, laboratory tests were taken and adverse events were recorded at every visit. Participants were followed up at 6, 12 weeks, 6, 12 months and 2 years after injection. The primary outcome measure was the improvement in pain at activity at 3 months after injection. Results: Twenty-three patients were included in the final analysis. Primary outcome did not differ among groups (p = 0.35). A mixed effect model revealed no statistically significant interactions. Only time significantly predicted the outcome measure. All participants reported transient pain at the injection site. There were no differences in post-injection pain duration or severity. Safety measures did not differ between groups, and there were no persistent adverse events.Conclusions: Stem cell injection into supraspinatus partial tears in patients with shoulder pain lasting more than 3 months was not more effective than control injections. (ClinicalTrials.gov Identifier: NCT02298023)

scholarly journals Estimates of the mean difference in orthopaedic randomized trials: obligatory yet obscure

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Lauri Raittio ◽  
Antti Launonen ◽  
Ville M. Mattila ◽  
Aleksi Reito
Keyword(s):  
Primary Outcome ◽  
Outcome Measure ◽  
Patient Reported Outcome ◽  
Ceiling Effect ◽  
Mean Difference ◽  
Discussion Section ◽  
Power Calculations ◽  
Randomized Controlled ◽  
Patient Reported ◽  
The Mean

Abstract Background Randomized controlled trials in orthopaedics are powered to mainly find large effect sizes. A possible discrepancy between the estimated and the real mean difference is a challenge for statistical inference based on p-values. We explored the justifications of the mean difference estimates used in power calculations. The assessment of distribution of observations in the primary outcome and the possibility of ceiling effects were also assessed. Methods Systematic review of the randomized controlled trials with power calculations in eight clinical orthopaedic journals published between 2016 and 2019. Trials with one continuous primary outcome and 1:1 allocation were eligible. Rationales and references for the mean difference estimate were recorded from the Methods sections. The possibility of ceiling effect was addressed by the assessment of the weighted mean and standard deviation of the primary outcome and its elaboration in the Discussion section of each RCT where available. Results 264 trials were included in this study. Of these, 108 (41 %) trials provided some rationale or reference for the mean difference estimate. The most common rationales or references for the estimate of mean difference were minimal clinical important difference (16 %), observational studies on the same subject (8 %) and the ‘clinical relevance’ of the authors (6 %). In a third of the trials, the weighted mean plus 1 standard deviation of the primary outcome reached over the best value in the patient-reported outcome measure scale, indicating the possibility of ceiling effect in the outcome. Conclusions The chosen mean difference estimates in power calculations are rarely properly justified in orthopaedic trials. In general, trials with a patient-reported outcome measure as the primary outcome do not assess or report the possibility of the ceiling effect in the primary outcome or elaborate further in the Discussion section.

Stem Cell, Fibrin Glue, and Normal Saline on Partially Torn Tendons: An RCT

2021 ◽  
Author(s):  
Se-Woong Chun ◽  
Won Kim ◽  
Sang Yoon Lee ◽  
Chai-Young Lim ◽  
Keewon Kim ◽  
...  
Keyword(s):  
Stem Cell ◽  
Fibrin Glue ◽  
Normal Saline

A systematic review of ketamine for the treatment of depression among older adults

2020 ◽  
pp. 1-13
Author(s):  
Aarti Gupta ◽  
Romika Dhar ◽  
Palak Patadia ◽  
Melissa Funaro ◽  
Gargi Bhattacharya ◽  
...  
Keyword(s):  
Older Adults ◽  
Adverse Effects ◽  
Primary Outcome ◽  
Rating Scale ◽  
Outcome Measure ◽  
Primary Outcome Measure ◽  
Current Evidence ◽  
Depression Symptoms ◽  
Randomized Controlled ◽  
Treatment Of Depression

Abstract Objective: To review the currently available data on the use of ketamine in the treatment of depression among older adults from randomized controlled studies. Design: Randomized controlled trials. Setting: Variable. Participants: 60 years and older with depression. Intervention: Ketamine. Measurements: Change in Montgomery–Asberg Depression Rating Scale (MADRS) scores. Results: Two studies met the inclusion criteria. The first study showed a significant reduction in depression symptoms with use of repeated subcutaneous ketamine administration among older adults with depression. The second study failed to achieve significance on its primary outcome measure but did show a decrease in MADRS scores with intranasal ketamine along with a higher response and remission rates in esketamine group compared with the placebo group. The adverse effects from ketamine generally lasted only a few hours and abated spontaneously. No cognitive adverse effects were noted in either trial from the use of ketamine. Conclusions: The current evidence for use of ketamine among older adults with depression indicates some benefits with one positive and one negative trial. Although one of the trials did not achieve significance on the primary outcome measure, it still showed benefit of ketamine in reducing depressive symptoms. Ketamine was well tolerated in both studies with adverse effects being mild and transient.

Acupuncture for episodic tension-type headache: a multicentre randomized controlled trial

Cephalalgia ◽  
2000 ◽  
Vol 20 (7) ◽  
pp. 632-637 ◽  
Author(s):  
AR White ◽  
K-L Resch ◽  
JCK Chan ◽  
CD Norris ◽  
SK Modi ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Outcome Measure ◽  
Controlled Trial ◽  
Primary Outcome Measure ◽  
Tension Type Headache ◽  
Control Procedure ◽  
Randomized Controlled ◽  
Type Headache ◽  
To Receive ◽  
Time Point

A multicentre, randomized clinical trial was undertaken to test the hypothesis that acupuncture is more efficacious than sham control procedure in the prevention of episodic tension-type headache. Fifty subjects were randomized to receive a course of treatment with either brief acupuncture or a sham procedure. Subjects were followed up for 3 months. Changes in headache were assessed by daily diary, the primary outcome measure being the number of days with headache. No significant differences were found between the changes in the two groups for any measure at any time point. Results also show that patient blinding was successful. In conclusion, this study does not provide evidence that this form of acupuncture is effective in the prevention of episodic tension-type headache.

scholarly journals Efficacy of intravenous lidocaine infusions for pain relief in children undergoing laparoscopic appendectomy: a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Maciej Kaszyński ◽  
Dorota Lewandowska ◽  
Piotr Sawicki ◽  
Piotr Wojcieszak ◽  
Izabela Pągowska-Klimek
Keyword(s):  
Laparoscopic Appendectomy ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Control Group ◽  
Intravenous Lidocaine ◽  
Lidocaine Group ◽  
Randomized Controlled ◽  
Fentanyl Consumption

Abstract Intravenous lidocaine, a potent local anesthetic with analgesic and anti-inflammatory properties, has been shown to be an effective adjunct that reduces intra- and postoperative opioid consumption and facilitates pain management in adults. While it shows promise for use in the pediatric population, limited evidence is available. Objectives To determine if general anesthesia with intraoperative intravenous lidocaine infusion versus general anesthesia without intravenous lidocaine infusion in children undergoing laparoscopic appendectomy decreased opioid requirements intra- and postoperatively. Design A single-center parallel single-masked randomized controlled study. A computer-generated blocked randomization list was used to allocate participants. The study was conducted between March 2019 and January 2020. Setting: Pediatric teaching hospital in Poland. Participants Seventy-four patients aged between 18 months and 18 years undergoing laparoscopic appendectomy. Seventy-one patients fulfilled the study requirements. Intervention Intravenous lidocaine bolus of 1.5 mg/kg over 5 min before induction of anesthesia followed by lidocaine infusion at 1.5 mg/kg/h intraoperatively. The infusion was discontinued before the patients’ transfer to the postanesthesia care unit (PACU). Primary outcome measure The primary outcome measure was total nalbuphine requirement in milligrams during the first 24 h after surgery. Secondary outcome measures The secondary outcome measures were intraoperative fentanyl consumption, intraoperative sevoflurane consumption, time to the first rescue analgesic request, incidence of postoperative nausea and vomiting during the first 24 h after surgery, frequency of side effects of lidocaine. Results Children (n = 74) aged 5–17 randomly allocated to receive intraoperative lidocaine infusion (n = 37) or no intervention (n = 37). Seventy-one were included in the analysis (35 in the study group and 36 in the control group). There was no difference in the cumulative dose of nalbuphine in the first 24 h after removal of the endotracheal tube between groups [median of 0.1061 (IQR: 0.0962–0.2222) mg/kg in the lidocaine group, compared to the control group median of 0.1325 (IQR: 0.0899–0.22020) mg/kg, p = 0.63]. Intraoperative fentanyl consumption was lower in the lidocaine group [median of 5.091 (IQR: 4.848–5.714) μg/kg] than in the control group [median of 5.969 (IQR: 5.000–6.748), p = 0.03]. Taking into account the additional doses administered based on clinical indications, the reduction in the requirement for fentanyl in the lidocaine group was even greater [median of 0.0 (IQR: 0.0–0.952) vs 0.99 (IQR: 0.0–1.809) μg/kg, p = 0.01]. No difference was observed in the sevoflurane consumption between the two groups [median of 32.5 ml (IQR 25.0–43.0) in the lidocaine group vs median of 35.0 ml (IQR: 23.5–46.0) in the control group, p = 0.56]. The time to first analgesic request in the lidocaine group was prolonged [median of 55 (IQR: 40–110) min in the lidocaine group vs median of 40.5 (IQR: 28–65) min in the control group, p = 0.05]. There was no difference in the frequency of PONV between the two groups (48.57% in the lidocaine group vs 61.11% in the control group, p = 0.29). No lidocaine related incidence of anaphylaxis, systemic toxicity, circulatory disturbances or neurological impairment was reported, during anesthesia or postoperative period. Conclusions Intraoperative systemic lidocaine administration reduced the intraoperative requirement for opioids in children undergoing laparoscopic appendectomy. This effect was time limited, and hence did not affect opioid consumption in the first 24 h following discontinuation of lidocaine infusion. Trial registration NCT03886896.

scholarly journals Multiarm, multistage randomized controlled trials with stopping boundaries for efficacy and lack of benefit: An update to nstage

2019 ◽  
Vol 19 (4) ◽  
pp. 782-802 ◽  
Author(s):  
Alexandra Blenkinsop ◽  
Babak Choodari-Oskooei
Keyword(s):  
Primary Outcome ◽  
Randomized Clinical Trials ◽  
Outcome Measure ◽  
Primary Outcome Measure ◽  
Stopping Rules ◽  
Familywise Error Rate ◽  
Operating Characteristics ◽  
Randomized Controlled ◽  
Intermediate Outcomes ◽  
Additional Option

Royston et al.’s (2011, Trials 12: 81) multiarm, multistage (MAMS) framework for the design of randomized clinical trials uses intermediate outcomes to drop research arms early for lack of benefit at interim stages, increasing efficiency in multiarm designs. However, additionally permitting interim evaluation of efficacy on the primary outcome measure could increase adoption of the design and result in practical benefits, such as savings in patient numbers and cost, should any efficacious arm be identified early. The nstage command, which aids the design of MAMS trial designs, has been updated to support this methodological extension. Operating characteristics can now be calculated for a design with binding or nonbinding stopping rules for lack of benefit and with efficacy stopping boundaries. An additional option searches for a design that strongly controls the familywise error rate at the desired level. We illustrate how the new features can be used to design a trial with the drop-down menu, using the original comparisons from the MAMS trial STAMPEDE as an example. The new functionality of the command will serve a broader range of trial objectives and increase efficiency of the design and thus increase uptake of the MAMS design in practice.

Comparison of Percentage of Syllables Stuttered With Parent-Reported Severity Ratings as a Primary Outcome Measure in Clinical Trials of Early Stuttering Treatment

2018 ◽  
Vol 61 (4) ◽  
pp. 811-819 ◽  
Author(s):  
Mark Onslow ◽  
Mark Jones ◽  
Sue O'Brian ◽  
Ann Packman ◽  
Ross Menzies ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Trials ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Primary Outcome Measure ◽  
Analysis Of Covariance ◽  
Data Sets ◽  
Randomized Controlled ◽  
Absolute Agreement

Purpose This report investigates whether parent-reported stuttering severity ratings (SRs) provide similar estimates of effect size as percentage of syllables stuttered (%SS) for randomized trials of early stuttering treatment with preschool children. Method Data sets from 3 randomized controlled trials of an early stuttering intervention were selected for analyses. Analyses included median changes and 95% confidence intervals per treatment group, Bland–Altman plots, analysis of covariance, and Spearman rho correlations. Results Both SRs and %SS showed large effect sizes from pretreatment to follow-up, although correlations between the 2 measures were moderate at best. Absolute agreement between the 2 measures improved as percentage reduction of stuttering frequency and severity increased, probably due to innate measurement limitations for participants with low baseline severity. Analysis of covariance for the 3 trials showed consistent results. Conclusion There is no statistical reason to favor %SS over parent-reported stuttering SRs as primary outcomes for clinical trials of early stuttering treatment. However, there are logistical reasons to favor parent-reported stuttering SRs. We conclude that parent-reported rating of the child's typical stuttering severity for the week or month prior to each assessment is a justifiable alternative to %SS as a primary outcome measure in clinical trials of early stuttering treatment.

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