scholarly journals Protocol for prospective randomised assessor-blinded pilot study comparing hyperbaric oxygen therapy with PENtoxifylline+TOcopherol± CLOdronate for the management of early osteoradionecrosis of the mandible

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e026662 ◽  
Author(s):  
Vishal M Bulsara ◽  
Max K Bulsara ◽  
Emma Lewis
Keyword(s):  
Pilot Study ◽  
Hyperbaric Oxygen ◽  
Controlled Trials ◽  
Early Management ◽  
Intention To Treat ◽  
Treatment Standard ◽  
The Usa ◽  
Pre Treatment ◽  
Randomised Controlled

IntroductionOsteoradionecrosis (ORN) of the mandible is a painful and debilitating condition occurring after radiotherapy to the head and neck to treat cancer. For decades, hyperbaric oxygen (HBO) has formed the mainstay of the early management of ORN. Literature about the efficacy of HBO is contentious. Recently, Oral and Maxillofacial surgical units in France and UK have trialled a combination of medications to treat ORN, also known as PENTOCLO (PENtoxifylline+TOcopherol±CLOdronate). This regime has shown promising results to date however randomised controlled trials in the area comparing HBO against PENTOCLO are lacking and there are no current trials registered in Europe, UK, Australia and the USA. The purpose of this pilot study is to generate a hypothesis that can be tested in large multi-centre controlled trials.Methods and analysisFor this pilot study we will recruit 16 patients who will be randomly allocated to one of either HBO or PENTOCLO. After a 4 week period of uniform ‘pre-treatment’ medication patients will be commenced on their allocated treatment. Standard follow-up examination, imaging and photographs will be taken and de-identified and then presented to two Oral and Maxillofacial surgeons for allocation of a Notani & Lyons classification score. Data for each patient will be tracked over the 18 months of treatment and follow-up. The results will then be analysed using descriptive statistics and all patients included in an intention to treat analysis.Ethics and disseminationEthical approval for this study has been granted by the South Metropolitan Health Service HREC (PRN RGS0000001193). Data generated by conducting this study will be uploaded to an open access repository in a de-identified form. Results from this study will be disseminated at national and international conferences as well as peer reviewed medical publications.Trial registration numberACTRN12618001099213; Pre-results.

scholarly journals Randomised controlled trials (RCTs) in sports injury research: authors—please report the compliance with the intervention

2019 ◽  
Vol 54 (1) ◽  
pp. 51-57 ◽  
Author(s):  
Rasmus Oestergaard Nielsen ◽  
Michael Lejbach Bertelsen ◽  
Daniel Ramskov ◽  
Camma Damsted ◽  
Evert Verhagen ◽  
...  
Keyword(s):  
Randomised Controlled Trials ◽  
Sports Injury ◽  
Controlled Trials ◽  
Quality Reporting ◽  
Intention To Treat ◽  
Full Compliance ◽  
Running Shoes ◽  
Randomised Controlled ◽  
Analytical Approaches

BackgroundIn randomised controlled trials (RCTs) of interventions that aim to prevent sports injuries, the intention-to-treat principle is a recommended analysis method and one emphasised in the Consolidated Standards of Reporting Trials (CONSORT) statement that guides quality reporting of such trials. However, an important element of injury prevention trials—compliance with the intervention—is not always well-reported. The purpose of the present educational review was to describe the compliance during follow-up in eight large-scale sports injury trials and address compliance issues that surfaced. Then, we discuss how readers and researchers might consider interpreting results from intention-to-treat analyses depending on the observed compliance with the intervention.MethodsData from seven different randomised trials and one experimental study were included in the present educational review. In the trials that used training programme as an intervention, we defined full compliance as having completed the programme within ±10% of the prescribed running distance (ProjectRun21 (PR21), RUNCLEVER, Start 2 Run) or time-spent-running in minutes (Groningen Novice Running (GRONORUN)) for each planned training session. In the trials using running shoes as the intervention, full compliance was defined as wearing the prescribed running shoe in all running sessions the participants completed during follow-up.ResultsIn the trials that used a running programme intervention, the number of participants who had been fully compliant was 0 of 839 (0%) at 24-week follow-up in RUNCLEVER, 0 of 612 (0%) at 14-week follow-up in PR21, 12 of 56 (21%) at 4-week follow-up in Start 2 Run and 8 of 532 (1%) at 8-week follow-up in GRONORUN. In the trials using a shoe-related intervention, the numbers of participants who had been fully compliant at the end of follow-up were 207 of 304 (68%) in the 21 week trial, and 322 of 423 (76%), 521 of 577 (90%), 753 of 874 (86%) after 24-week follow-up in the other three trials, respectively.ConclusionThe proportion of runners compliant at the end of follow-up ranged from 0% to 21% in the trials using running programme as intervention and from 68% to 90% in the trials using running shoes as intervention. We encourage sports injury researchers to carefully assess and report the compliance with intervention in their articles, use appropriate analytical approaches and take compliance into account when drawing study conclusions. In studies with low compliance, G-estimation may be a useful analytical tool provided certain assumptions are met.

Efficacy of electronic cigarettes for tobacco smoking cessation: An adapted systematic review

2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
T O'Dowd
Keyword(s):  
Smoking Cessation ◽  
Cohort Studies ◽  
Randomised Controlled Trials ◽  
Electronic Cigarettes ◽  
Controlled Trials ◽  
Significant Heterogeneity ◽  
Smoking Reduction ◽  
Significant Difference ◽  
Randomised Controlled

Abstract Background Worldwide smoking remains the leading cause of preventable morbidity and mortality. Electronic cigarettes (ECs) are increasingly used by tobacco smokers as an aid to smoking cessation; however, their efficacy remains uncertain. Methods Electronic databases, clinical trial registries and grey literature sources were searched. The aim was to examine randomised controlled trials or prospective cohort studies, published since the 2016 Cochrane review on this topic, that assessed the efficacy of ECs in achieving smoking cessation among current smokers. Results Two RCTs and five cohort studies, including a total of 16,460 participants, were eligible for inclusion. One RCT found sustained 1-year abstinence of 18.0% in the EC group versus 9.9% in the nicotine replacement therapy group (RR: 1.83; 95% CI 1.30 to 2.58; P < 0.001). The second RCT did not find a statistically significant difference in abstinence rates between EC users and non-users (RR 0.71). Of the five included cohort studies, four reported statistically significant RRs. Two found a positive association (RRs of 1.45 and 1.84) between EC use and smoking cessation but two studies showed EC use was associated with reduced smoking cessation (RRs of 0.25 and 0.35). Due to significant heterogeneity between the studies the data were deemed unsuitable for pooling into a meta-analysis. All trials assessing smoking reduction reported higher rates of reduction among EC users. No serious adverse events were reported with EC use. Follow-up periods of included trials ranged from one to four years, with an average of 1.6 years. Conclusions There is limited, low-quality evidence that ECs are an effective intervention for smoking cessation and smoking reduction. The overall quality of evidence is low as it is based on a small number of studies with inconsistent and imprecise results. Due to the short follow-up periods of the included trials, the long-term safety of ECs is unclear from this review. Key messages Limited evidence that electronic cigarettes are an effective smoking cessation intervention. Further well-designed randomised controlled trials are required to investigate the efficacy of ECs for smoking cessation.

scholarly journals OP0287 IMMUNOMODULATORY THERAPIES FOR SEVERE FORMS OF COVID-19: A SYSTEMATIC LITERATURE REVIEW TO INFORM EULAR POINTS TO CONSIDER

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 175.1-175
Author(s):  
A. Alunno ◽  
A. Najm ◽  
X. Mariette ◽  
J. Emmel ◽  
L. Mason ◽  
...  
Keyword(s):  
Risk Of Bias ◽  
Respiratory Support ◽  
Disease Stage ◽  
Controlled Trials ◽  
Immunomodulatory Agents ◽  
Randomised Controlled ◽  
Available Information ◽  
Immunomodulatory Therapies ◽  
Global Health Problem

Background:The severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) pandemic is a global health problem. Beside the specific pathogenic effect of SARS-CoV-2, a deleterious aberrant non-effective host immune response plays an important role especially in severe forms of COVID-19. There is intense investigation to explore the utility of immunomodulatory drugs commonly used in the Rheumatology arena as agents that may mitigate against COVID-19 to improve disease prognosis. Rheumatologists are used to the utilization of these immune targeted therapies.Objectives:To summarize the available information on the use of immunomodulatory agents in severe COVID-19.Methods:As part of a EULAR taskforce, a systematic literature search was conducted from January 2019 up to December 11, 2020. Two reviewers independently identified eligible studies according to the PICO framework P (population): patients with SARS-CoV-2 infection; I (intervention): any immunomodulator agent/strategy; C (comparator): any comparator; O (outcome) any clinical outcome including but not limited to mortality, admission to intensive care unit and clinical improvement. Data on efficacy and safety of immunomodulatory agents utilized therapeutically in SARS-CoV-2 infection at any stage were extracted. The risk of bias was assessed using validated tools.Results:Of 60372 records, 401 articles were eligible for inclusion. Studies were at variable risk of bias. Randomised controlled trials (RCTs) were available for the following drugs: hydroxychloroquine (N=12), glucocorticoids (N=6), tocilizumab (N= 4), convalescent plasma (N=4), interferon beta (N=2), IVIg (N=2) and N=1 each for anakinra, baricitinib, colchicine, leflunomide, ruxolitinib, interferon kappa, and vilobelimab. For glucocorticoids, dexamethasone reduced mortality only in patients requiring respiratory support; while methylprednisolone reduced mortality in patients aged 60 years or over. Data from RCTs on tocilizumab are conflicting and definite conclusions cannot be drawn at this point in time, but recent studies suggest possible benefit in patients requiring respiratory support. Hydroxychloroquine was not beneficial at any disease stage, one RCT with anakinra was negative, one RCT with baricitinib+remdesivir was positive, and individual trials testing some other compounds provided interesting, albeit preliminary, results.Conclusion:Although there is emerging evidence about immunomodulatory therapies for the management of COVID-19, conclusive data is scarce with some conflicting data. Since glucocorticoids seem to improve survival in some subsets of patients, RCTs comparing glucocorticoids alone versus glucocorticoids plus anti-cytokine/immunomodulatory treatment are warranted. This SLR informed the initiative to formulate EULAR points to consider on pathophysiology and use of immunomodulatory therapies in COVID-19.Figure 1.Forest plots showing the risk ratio (RR) and 95% confidence interval for mortality in randomized controlled trials divided by intervention. The latest follow-up available is reported in the timing column.Disclosure of Interests:None declared

scholarly journals Potential impact on estimated treatment effects of information lost to follow-up in randomised controlled trials (LOST-IT): systematic review

BMJ ◽  
2012 ◽  
Vol 344 (may18 1) ◽  
pp. e2809-e2809 ◽  
Author(s):  
E. A. Akl ◽  
M. Briel ◽  
J. J. You ◽  
X. Sun ◽  
B. C. Johnston ◽  
...  
Keyword(s):  
Systematic Review ◽  
Randomised Controlled Trials ◽  
Treatment Effects ◽  
Controlled Trials ◽  
Potential Impact ◽  
Randomised Controlled ◽  
Lost To Follow Up

scholarly journals Relative effectiveness of a full versus reduced version of the ‘Smoke Free’ mobile application for smoking cessation: a randomised controlled trial

F1000Research ◽  
2018 ◽  
Vol 7 ◽  
pp. 1524 ◽  
Author(s):  
David Crane ◽  
Harveen Kaur Ubhi ◽  
Jamie Brown ◽  
Robert West
Keyword(s):  
Smoking Cessation ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Relative Effectiveness ◽  
Behaviour Change Techniques ◽  
Full Version ◽  
Intention To Treat ◽  
Support Programmes ◽  
Randomised Controlled

Background: Smartphone applications (apps) are popular aids for smoking cessation. Smoke Free is an app that delivers behaviour change techniques used in effective face-to-face behavioural support programmes. The aim of this study was to assess whether the full version of Smoke Free is more effective than the reduced version. Methods:  This was a two-arm randomised controlled trial. Smokers who downloaded Smoke Free were randomly offered the full or reduced version; 28,112 smokers aged 18+ years who set a quit date were included. The full version provided updates on benefits of abstinence, progress (days smoke free), virtual ‘badges’ and daily ‘missions’ with push notifications aimed at preventing and managing cravings. The reduced version did not include the missions. At baseline the app recorded users’: device type (iPhone or Android), age, sex, daily cigarette consumption, time to first cigarette of the day, and educational level. The primary outcome was self-reported complete abstinence from the quit date in a 3-month follow-up questionnaire delivered via the app. Analyses conducted included logistic regressions of outcome on to app version (full versus reduced) with adjustment for baseline variables using both intention-to-treat/missing-equals smoking (MES) and follow-up-only (FUO) analyses. Results: The 3-month follow-up rate was 8.5% (n=1,213) for the intervention and 6.5% (n=901) for the control. A total of 234 participants reported not smoking in the intervention versus 124 in the control, representing 1.6% versus 0.9% in the MES analysis and 19.3% versus 13.8% in the FUO analysis. Adjusted odds ratios were 1.90, 95%CI=1.53-2.37 (p<0.001) and 1.50, 95%CI=1.18-1.91 (p<0.001) in the MES and FUO analyses respectively. Conclusions: Despite very low follow-up rates using in-app follow up, both intention-to-treat/missing equals smoking and follow-up only analyses showed the full version of the Smoke Free app to result in higher self-reported 3-month continuous smoking abstinence rates than the reduced version.

scholarly journals The impact of a run-in period on treatment effects in cardiovascular prevention randomised control trials: A protocol for a comprehensive review and meta-analysis

2020 ◽  
Vol 3 ◽  
pp. 82
Author(s):  
Robert Murphy ◽  
Emer McGrath ◽  
Aoife Nolan ◽  
Andrew Smyth ◽  
Michelle Canavan ◽  
...  
Keyword(s):  
Randomised Controlled Trials ◽  
Treatment Effects ◽  
Meta Analysis ◽  
Cardiovascular Prevention ◽  
Controlled Trials ◽  
Loss To Follow Up ◽  
Relative Risks ◽  
Prevention Trials ◽  
Randomised Controlled

Background: A run-in period is often employed in randomised controlled trials to increase adherence to the intervention and reduce participant loss to follow-up in the trial population. However, it is uncertain whether use of a run-in period affects the magnitude of treatment effect. Methods: We will conduct a sensitive search for systematic reviews of cardiovascular preventative trials and a complete meta-analysis of treatment effects comparing cardiovascular prevention trials using a run-in period (“run-in trials”) with matched cardiovascular prevention trials that did not use a run-in period (“non-run-in trials”). We describe a comprehensive matching process which will match run-in trials with non-run-in trials by patient populations, interventions, and outcomes. For each pair of run-in trial and matched non-run-in trial(s), we will estimate the ratio of relative risks and 95% confidence interval. We will evaluate differences in treatment effect between run-in and non-run-in trials and our and our priamry outcome will be the ratio of relative risks for matched run-in and non-run-in trials for their reported cardiovascular composite outcome. Our secondary outcomes are comparisons of mortality, loss to follow up, frequency of adverse events and methodological quality of trials. Conclusions: This study will answer a key question about what influence a run-in period has on the magnitude of treatment effects in randomised controlled trials for cardiovascular prevention therapies.

Effect of action observation therapy on motor function in children with cerebral palsy: a systematic review of randomized controlled trials with meta-analysis

2020 ◽  
pp. 026921552095434
Author(s):  
Naglaa Abdelhaleem ◽  
Samar Taher ◽  
Menna Mahmoud ◽  
Ahmad Hendawy ◽  
Maged Hamed ◽  
...  
Keyword(s):  
Cerebral Palsy ◽  
Methodological Quality ◽  
Randomised Controlled Trials ◽  
Action Observation ◽  
Meta Analysis ◽  
Post Treatment ◽  
Controlled Trials ◽  
Children With Cerebral Palsy ◽  
Randomised Controlled

Objective: To evaluate the evidence of using Action Observation Therapy in the rehabilitation of children with Cerebral Palsy. Study design: Systematic review with meta-analysis of Randomised Controlled Trials. Methods: For the purpose of identifying relevant studies, six databases were searched from inception until July 2020. The methodological quality was assessed by Physiotherapy Evidence Database scale. The outcomes were classified within the framework of the International Classification of Functioning. A pooled meta-analysis was performed on studies that demonstrated homogeneity. Results: Twelve randomised controlled trials with 307 participants were included with six of them were included in the meta-analysis. Non-significant difference between the groups was demonstrated by meta-analysis. Results of capacity assessed in post treatment and follow up evaluation were (0.06, –0.22 to 0.34, 95% (CI); P = 0.69 and (–0.35, –0.96 to 0.27, 95% (CI); P = 0.27); respectively. Actual performance in post-treatment and follow up were (0.10, –0.22 to 0.48, 95% (CI); P = 0.62) and (0.01, –0.40 to 0.41, 95% (CI); P = 0.97); respectively. Perceived performance evaluated using (ABILHAND-KIDS) were (0.30, –0.28 to 0.89, 95% (CI); P = 0.31) and (0.15, –0.43 to 0.73, 95% (CI); P = 0.61) for post treatment and follow up; respectively. Overall effect on activity domain was (0.08, –0.11 to 0.28, 95% (CI); P = 0.86) immediately and (0.04, –0.33 to 0.26, 95% (CI); P = 0.49) at follow-up; respectively. Conclusion: No evidence of benefit had been found to draw a firm conclusion regarding the effectiveness of action observation therapy in the rehabilitation of children with cerebral palsy due to limitations in methodological quality and variations between studies.

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