scholarly journals Determining the Feasibility of Ambulance-Based Randomised Controlled Trials in Patients with Ultra-Acute Stroke: Study Protocol for the “Rapid Intervention with GTN in Hypertensive Stroke Trial” (RIGHT, ISRCTN66434824)

2012 ◽  
Vol 2012 ◽  
pp. 1-10 ◽  
Author(s):  
Sandeep Ankolekar ◽  
Gillian Sare ◽  
Chamila Geeganage ◽  
Michael Fuller ◽  
Lynn Stokes ◽  
...  
Keyword(s):  
Acute Stroke ◽  
Functional Outcomes ◽  
Randomised Controlled Trials ◽  
Controlled Trial ◽  
Trial Registration ◽  
Controlled Trials ◽  
Stroke Study ◽  
Registration Number ◽  
Randomised Controlled ◽  
The Uk

Background. Time from acute stroke to enrolment in clinical trials needs to be reduced to improve the chances of finding effective treatments. No completed randomised controlled trials of ambulance-based treatment for acute stroke have been reported in the UK, and the practicalities of recruiting, consenting, and treating patients are unknown.Methods. RIGHT is an ambulance based, single-blind, randomised controlled trial with blinded-outcome assessment. The trial will assess feasibility of using ambulance services to deliver ultra-acute stroke treatments; a secondary aim is to assess the effect of glyceryl trinitrate (GTN) on haemodynamic variables and functional outcomes. Initial consent, randomisation, and treatment are performed by paramedics prior to hospitalisation. Patients with ultra-acute stroke (≤4 hours of onset) are randomised to transdermal GTN (5 mg/24 hours) or gauze dressing daily for 7 days. The primary outcome is systolic blood pressure at 2 hours. Secondary outcomes include feasibility, haemodynamics, dependency, and other functional outcomes. A nested qualitative study is included.Trial Status. The trial has all relevant ethics and regulatory approvals and recruitment started on February 15, 2010. The trial stopped recruitment in December 2011 after 41 patients were recruited.Trial Registration. The trial registration number is ISRCTN66434824 and EudraCT number is 2007-004766-40.

scholarly journals A survey of instructions to authors in surgical journals on reporting by CONSORT and PRISMA

2012 ◽  
Vol 94 (7) ◽  
pp. 468-471 ◽  
Author(s):  
S Shantikumar ◽  
J Wigley ◽  
W Hameed ◽  
A Handa
Keyword(s):  
Systematic Reviews ◽  
Randomised Controlled Trials ◽  
Trial Registration ◽  
Controlled Trials ◽  
Clinical Trial Registration ◽  
Journal Citation Reports ◽  
Randomised Controlled ◽  
The Uk ◽  
Meta Analyses ◽  
Surgical Journals

INTRODUCTION Guidance has been published on how best to report randomised controlled trials (Consolidated Standards of Reporting Trials – CONSORT) and systematic reviews (Preferred Reporting Items for Systematic Reviews and Meta-Analyses – PRISMA). The aim of this study was to establish to what extent surgical journals formally endorse CONSORT and PRISMA in the respective reporting of randomised controlled trials and systematic reviews. METHODS Overall, 136 surgical journals indexed in Journal Citation Reports® were studied. Author guidelines were scrutinised for the following guidance: conflict of interests (COI), the Uniform Requirements for Manuscripts (URM), clinical trial registration, CONSORT and PRISMA. RESULTS The frequency of guidance endorsement was found to be as follows: COI 82%, URM 62%, trial registration 32%, CONSORT 29% and PRISMA 10%. Journals with a higher impact were more likely to adopt trial registration, CONSORT and PRISMA. Journals with editorial offices in the UK were more likely to insist on disclosure of COI and to endorse CONSORT. CONCLUSIONS Guidelines produced to improve publication practice have not been implemented widely by surgical journals. This may contribute to an overall poorer quality of published research. Editors of surgical journals should uniformly endorse reporting guidance and update their instructions to authors to reflect this.

scholarly journals The association between registration status and reported outcomes in physiotherapy randomised controlled trials

2020 ◽  
Vol 27 (3) ◽  
pp. 1-15
Author(s):  
Christopher Ellaway-Barnard ◽  
Hannah Killick ◽  
Guy Peryer ◽  
Jane L Cross ◽  
Toby O Smith
Keyword(s):  
Randomised Controlled Trials ◽  
Multivariate Analyses ◽  
Trial Registration ◽  
Selective Reporting ◽  
Controlled Trials ◽  
Included Trial ◽  
Clinical Trial Registration ◽  
Registration Status ◽  
Registration Number ◽  
Randomised Controlled

Background/Aims Clinical trial registration has been proposed as a method of mitigating selective reporting in scientific research. It remains unknown whether trial registration is associated with reported outcomes in physiotherapy trials. This study aimed to analyse the association between registration status and outcome (the rejection or acceptance of a primary null hypothesis) for physiotherapy randomised controlled trials. Methods All randomised controlled trials reporting a physiotherapy intervention in publications listed in PubMed between 1 January 2017 and 30 June 2017 were included. Trial registration was determined based on the reporting of a registration number in the primary article or by identifying trials through trial registries. Results Of the 291 trials analysed, 176 (60.5%) were registered; 115 (39.5%) were not. There was no significant association between trial registration and outcome on multivariate analyses (Odds Ratio 1.65; 95% Confidence Interval (0.92–2.96); P=0.09). Only 22% of trials were prospectively registered. Conclusions Registration status and trial outcome are not associated in randomised controlled trials of physiotherapy interventions. The rate of physiotherapy trial registration remains low.

scholarly journals Placebo comparator group selection and use in surgical trials: the ASPIRE project including expert workshop

2021 ◽  
Vol 25 (53) ◽  
pp. 1-52
Author(s):  
David J Beard ◽  
Marion K Campbell ◽  
Jane M Blazeby ◽  
Andrew J Carr ◽  
Charles Weijer ◽  
...  
Keyword(s):  
Randomised Controlled Trials ◽  
Medical Research Council ◽  
Placebo Control ◽  
Controlled Trials ◽  
Surgical Trials ◽  
Surgical Interventions ◽  
Placebo Controls ◽  
Randomised Controlled ◽  
The Uk ◽  
Future Work

Background The use of placebo comparisons for randomised trials assessing the efficacy of surgical interventions is increasingly being considered. However, a placebo control is a complex type of comparison group in the surgical setting and, although powerful, presents many challenges. Objectives To provide a summary of knowledge on placebo controls in surgical trials and to summarise any recommendations for designers, evaluators and funders of placebo-controlled surgical trials. Design To carry out a state-of-the-art workshop and produce a corresponding report involving key stakeholders throughout. Setting A workshop to discuss and summarise the existing knowledge and to develop the new guidelines. Results To assess what a placebo control entails and to assess the understanding of this tool in the context of surgery is considered, along with when placebo controls in surgery are acceptable (and when they are desirable). We have considered ethics arguments and regulatory requirements, how a placebo control should be designed, how to identify and mitigate risk for participants in these trials, and how such trials should be carried out and interpreted. The use of placebo controls is justified in randomised controlled trials of surgical interventions provided that there is a strong scientific and ethics rationale. Surgical placebos might be most appropriate when there is poor evidence for the efficacy of the procedure and a justified concern that results of a trial would be associated with a high risk of bias, particularly because of the placebo effect. Conclusions The use of placebo controls is justified in randomised controlled trials of surgical interventions provided that there is a strong scientific and ethics rationale. Feasibility work is recommended to optimise the design and implementation of randomised controlled trials. An outline for best practice was produced in the form of the Applying Surgical Placebo in Randomised Evaluations (ASPIRE) guidelines for those considering the use of a placebo control in a surgical randomised controlled trial. Limitations Although the workshop participants involved international members, the majority of participants were from the UK. Therefore, although every attempt was made to make the recommendations applicable to all health systems, the guidelines may, unconsciously, be particularly applicable to clinical practice in the UK NHS. Future work Future work should evaluate the use of the ASPIRE guidelines in making decisions about the use of a placebo-controlled surgical trial. In addition, further work is required on the appropriate nomenclature to adopt in this space. Funding Funded by the Medical Research Council UK and the National Institute for Health Research as part of the Medical Research Council–National Institute for Health Research Methodology Research programme.

scholarly journals Intra-articular saline injection as effective as corticosteroids, platelet-rich plasma and hyaluronic acid for hip osteoarthritis pain: a systematic review and network meta-analysis of randomised controlled trials

2020 ◽  
pp. bjsports-2020-102179
Author(s):  
Aaron Gazendam ◽  
Seper Ekhtiari ◽  
Anthony Bozzo ◽  
Mark Phillips ◽  
Mohit Bhandari
Keyword(s):  
Systematic Review ◽  
Functional Outcomes ◽  
Randomised Controlled Trials ◽  
Platelet Rich Plasma ◽  
Meta Analysis ◽  
Hip Osteoarthritis ◽  
Controlled Trials ◽  
Saline Injection ◽  
Randomised Controlled ◽  
Indirect Comparisons

ObjectiveIntra-articular (IA) injections represent a commonly used modality in the treatment of hip osteoarthritis (OA). Commonly used injections include corticosteroids (CCS), hyaluronic acid (HA) and platelet-rich plasma (PRP). A network meta-analysis allows for comparison among more than two treatment arms and uses both direct and indirect comparisons between interventions. The objective of this network meta-analysis is to compare the efficacy of the various IA injectable treatments in treating hip OA at up to 6 months of follow-up.DesignThis is a systematic review and network meta-analysis. Bayesian random-effects model was performed to assess the direct and indirect comparisons of all treatment options.Data sourcesPubMed, Embase, Cochrane Central Register of Controlled Trials, Scopus and Web of Science, from inception to October 2019.Eligibility criteria for selected studiesRandomised controlled trials assessing the efficacy of CCS, HA, PRP and placebo in the form of IA saline injection for patients with hip OA.ResultsEleven randomised controlled trials comprising 1353 patients were included. For pain outcomes at both 2–4 and 6 months, no intervention significantly outperformed placebo IA injection. For functional outcomes at both 2–4 and 6 months, no intervention significantly outperformed placebo IA injection. Regarding change from baseline at 2–4 months and 6 months, pooled data demonstrated that all interventions (including placebo), with the exception of HA+PRP, led to a clinically important improvement in both pain, exceeding the minimal clinically important difference.ConclusionEvidence suggests that IA hip saline injections performed as well as all other injectable options in the management of hip pain and functional outcomes.

scholarly journals Lowering blood pressure after acute intracerebral haemorrhage: protocol for a systematic review and meta-analysis using individual patient data from randomised controlled trials participating in the Blood Pressure in Acute Stroke Collaboration (BASC)

BMJ Open ◽  
2019 ◽  
Vol 9 (7) ◽  
pp. e030121 ◽  
Author(s):  
Tom J Moullaali ◽  
Xia Wang ◽  
Lisa J Woodhouse ◽  
Zhe Kang Law ◽  
Candice Delcourt ◽  
...  
Keyword(s):  
Systematic Review ◽  
Blood Pressure ◽  
Acute Stroke ◽  
Intracerebral Haemorrhage ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Patient Data ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Randomised Controlled

IntroductionConflicting results from multiple randomised trials indicate that the methods and effects of blood pressure (BP) reduction after acute intracerebral haemorrhage (ICH) are complex. The Blood pressure in Acute Stroke Collaboration is an international collaboration, which aims to determine the optimal management of BP after acute stroke including ICH.Methods and analysisA systematic review will be undertaken according to the Preferred Reporting Items for Systematic review and Meta-Analysis of Individual Participant Data (IPD) guideline. A search of Cochrane Central Register of Controlled Trials, EMBASE and MEDLINE from inception will be conducted to identify randomised controlled trials of BP management in adults with acute spontaneous (non-traumatic) ICH enrolled within the first 7 days of symptom onset. Authors of studies that meet the inclusion criteria will be invited to share their IPD. The primary outcome will be functional outcome according to the modified Rankin Scale. Safety outcomes will be early neurological deterioration, symptomatic hypotension and serious adverse events. Secondary outcomes will include death and neuroradiological and haemodynamic variables. Meta-analyses of pooled IPD using the intention-to-treat dataset of included trials, including subgroup analyses to assess modification of the effects of BP lowering by time to treatment, treatment strategy and patient’s demographic, clinical and prestroke neuroradiological characteristics.Ethics and disseminationNo new patient data will be collected nor is there any deviation from the original purposes of each study where ethical approvals were granted; therefore, further ethical approval is not required. Results will be reported in international peer-reviewed journals.PROSPERO registration numberCRD42019141136.

scholarly journals Recommendations from the ESO-Karolinska Stroke Update Conference, Stockholm 13–15 November 2016

2017 ◽  
Vol 2 (2) ◽  
pp. 95-102 ◽  
Author(s):  
Niaz Ahmed ◽  
Thorsten Steiner ◽  
Valeria Caso ◽  
Nils Wahlgren ◽  
Keyword(s):  
Randomised Controlled Trial ◽  
Randomised Controlled Trials ◽  
Consensus Statement ◽  
Controlled Trial ◽  
Strong Support ◽  
Controlled Trials ◽  
Scientific Programme ◽  
Statistical Review ◽  
Consensus Statements ◽  
Randomised Controlled

About the meeting: The purpose of the European Stroke Organisation (ESO)-Karolinska Stroke Update Conference is to provide updates on recent stroke therapy research and to give an opportunity for the participants to discuss how these results may be implemented into clinical routine. Several scientific sessions discussed in the meeting and each session produced consensus statements. The meeting started 20 years ago as Karolinska Stroke Update, but since 2014, it is a joint conference with ESO. Importantly, it provides a platform for discussion on the ESO guidelines process and on recommendations to the ESO guidelines committee on specific topics. By this, it adds a direct influence from stroke professionals otherwise not involved in committees and work groups on the guidelines procedure. The discussions at the conference may also inspire new guidelines when motivated. The topics raised at the meeting are selected by the scientific programme committee mainly based on recent important scientific publications. The ESO-Karolinska Stroke Update consensus statement and recommendations will be published every 2 years and it will work as implementation of ESO-guidelines Background This year’s ESO-Karolinska Stroke Update Meeting was held in Stockholm on 13–15 November 2016. There were 10 scientific sessions discussed in the meeting and each session produced a consensus statement ( Full version with background, issues, conclusions and references are published as web-material and at http://www.eso-karolinska.org/2016 and http://eso-stroke.org ) and recommendations which were prepared by a writing committee consisting of session chair(s), secretary and speakers and presented to the 312 participants of the meeting. In the open meeting, general participants commented on the consensus statement and recommendations and the final document were adjusted based on the discussion from the general participants. Recommendations (grade of evidence) were graded according to the 1998 Karolinska Stroke Update meeting with regard to the strength of evidence. Grade A Evidence: Strong support from randomised controlled trials and statistical reviews (at least one randomised controlled trial plus one statistical review). Grade B Evidence: Support from randomised controlled trials and statistical reviews (one randomised controlled trial or one statistical review). Grade C Evidence: No reasonable support from randomised controlled trials, recommendations based on small randomised and/or non-randomised controlled trials evidence.

scholarly journals A nested randomised controlled trial of a newsletter and Post-it® note did not increase postal questionnaire response rates in a falls prevention trial

F1000Research ◽  
2018 ◽  
Vol 7 ◽  
pp. 1083
Author(s):  
Sara Rodgers ◽  
Illary Sbizzera ◽  
Sarah Cockayne ◽  
Caroline Fairhurst ◽  
Sarah E. Lamb ◽  
...  
Keyword(s):  
Randomised Controlled Trials ◽  
Statistical Power ◽  
Controlled Trial ◽  
Meta Analysis ◽  
Response Rates ◽  
Postal Questionnaire ◽  
Falls Prevention ◽  
Controlled Trials ◽  
Questionnaire Response ◽  
Randomised Controlled

Background: Attrition (i.e. when participants do not return the questionnaires) is a problem for many randomised controlled trials. The resultant loss of data leads to a reduction in statistical power and can lead to bias. The aim of this study was to assess whether a pre-notification newsletter and/or a handwritten or printed Post-it® note sticker, as a reminder, increased postal questionnaire response rates for participants of randomised controlled trials. Method: This study was a factorial trial embedded within a trial of a falls-prevention intervention among men and women aged ≥65 years under podiatric care. Participants were randomised into one of six groups: newsletter plus handwritten Post-it®; newsletter plus printed Post-it®; newsletter only; handwritten Post-it® only; printed Post-it® only; or no newsletter or Post-it®. The results were combined with those from previous embedded randomised controlled trials in a meta-analysis. Results: The 12-month response rate was 803/826 (97.2%) (newsletter 95.1%, no newsletter 99.3%, printed Post-it® 97.5%, handwritten Post-it® 97.1%, no Post-it® 97.1%). Pre-notification with a newsletter had a detrimental effect on response rates (adjusted odds ratio (OR), 0.14; 95% CI, 0.04 to 0.48; p<0.01) and time to return the questionnaire (adjusted hazard ratio, 0.86; 95% CI, 0.75 to 0.99; p=0.04). No other statistically significant differences were observed between the intervention groups on response rates, time to response, and the need for a reminder. Conclusions: Post-it® notes have been shown to be ineffective in three embedded trials, whereas the evidence for newsletter reminders is still uncertain.

scholarly journals How do financial (dis)incentives influence health behaviour and costs? Protocol for a systematic literature review of randomised controlled trials

BMJ Open ◽  
2019 ◽  
Vol 9 (4) ◽  
pp. e024694
Author(s):  
Brittany Humphries ◽  
Andrew Irwin ◽  
Michael Zoratti ◽  
Feng Xie
Keyword(s):  
Financial Incentives ◽  
Randomised Controlled Trials ◽  
Cochrane Collaboration ◽  
Published Data ◽  
Controlled Trials ◽  
Comprehensive Overview ◽  
Clinical Trial Registries ◽  
Patient Health ◽  
Registration Number ◽  
Randomised Controlled

IntroductionIn this era of rising healthcare costs, there is a growing interest in understanding how funding policies can be used to improve health and healthcare efficiency. Financial incentives (eg, vouchers or access to health insurance) or disincentives (eg, fines or out-of-pocket costs) affect behaviours. To date, reviews have explored the effects of financial (dis)incentives on patient health and behaviour by focusing on specific behaviours or geographical areas. The objective of this systematic review is to provide a comprehensive overview on the use of financial (dis)incentives as a means of influencing health-related behaviour and costs in randomised trials.Methods and analysisWe will search electronic databases, clinical trial registries and websites of health economic organisations for randomised controlled trials. The initial searches, which were conducted on 13 January 2018, will be updated every 12 months until the completion of data analysis. The reference lists of included studies will be manually screened to identify additional eligible studies. Two researchers will independently review titles, abstracts and full texts to determine eligibility according to a set of predetermined inclusion criteria. Data will be extracted from included studies using a form developed and piloted by the research team. Discrepancies will be resolved through discussion with a third reviewer. Risk of bias will be assessed using the Cochrane Collaboration tool.Ethics and disseminationEthics approval is not required since this is a review of published data. Results will be disseminated through publication in peer-reviewed journals and presentations at relevant conferences.PROSPERO registration numberCRD42018097140

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