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.

Randomised Controlled Trials: Part 1, Design

2006 ◽  
Vol 69 (5) ◽  
pp. 217-223 ◽  
Author(s):  
Katherine H O Deane
Keyword(s):  
Randomised Controlled Trial ◽  
Occupational Therapy ◽  
Randomised Controlled Trials ◽  
Controlled Trial ◽  
Complex Interventions ◽  
Occupational Therapists ◽  
Research Tool ◽  
Controlled Trials ◽  
Randomised Controlled

Occupational therapists need to be able to evaluate the profession's interventions critically: to stop the ineffective, to reduce the hazardous and to promote the effective. Randomised controlled trials are a research tool for testing the efficacy of interventions with small to moderate effects. This review aims to cover the issues to be considered when designing a randomised controlled trial of complex interventions, such as occupational therapy.

scholarly journals Bah humbug! Association between sending Christmas cards to trial participants and trial retention: randomised study within a trial conducted simultaneously across eight host trials

BMJ ◽  
2021 ◽  
pp. e067742 ◽  
Author(s):  
Elizabeth Coleman ◽  
Catherine Arundel ◽  
Laura Clark ◽  
Laura Doherty ◽  
Katie Gillies ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Odds Ratio ◽  
Randomised Controlled Trials ◽  
Retention Rate ◽  
Controlled Trial ◽  
Controlled Trials ◽  
Study Within A Trial ◽  
Randomised Controlled ◽  
Trial Participants

Abstract Objectives To determine the effectiveness of sending Christmas cards to participants in randomised controlled trials to increase retention rate at follow-ups, and to explore the feasibility of doing a study within a trial (SWAT) across multiple host trials simultaneously. Design Randomised SWAT conducted simultaneously across eight host trials. Setting Eight randomised controlled trials researching various areas including surgery and smoking cessation. Participants 3223 trial participants who were still due at least one follow-up from their host randomised controlled trial. Intervention Participants were randomised (1:1, separately by each host trial) to either received a Christmas card in mid-December 2019 or to not receive a card. Main outcome measure Proportion of participants completing their next follow-up (retention rate) within their host randomised controlled trial. Results 1469 participants (age 16-94 years; 70% (n=1033) female; 96% (813/847) white ethnicity) across the eight host randomised controlled trials were involved in the analysis (cut short owing to covid-19). No evidence was found of a difference in retention rate between the two arms for any of the host trials when analysed separately or when the results were combined (85.3% (639/749) for cards versus 85.4% (615/720) for no card; odds ratio 0.96, 95% confidence interval 0.71 to 1.29; P=0.77). No difference was observed when comparing just participants who were due a follow-up in the 30 days after receiving the card (odds ratio 0.96, 0.42 to 2.21). No evidence of a difference in time to complete the questionnaire was found (hazard ratio 1.01, 95% confidence interval 0.91 to 1.13; P=0.80). These results were robust to post hoc sensitivity analyses. The cost of this intervention was £0.76 (€0.91; $1.02) per participant, and it will have a carbon footprint of approximately 140 g CO 2 equivalent per card. One benefit of this approach was the need to only submit one ethics application. Conclusions Sending Christmas cards to participants in randomised controlled trials does not increase retention. Undertaking a SWAT within multiple randomised controlled trials at the same time is, however, possible. This approach should be used more often to build an evidence base to support selection of recruitment and retention strategies. Although no evidence of a boost to retention was found, embedding a SWAT in multiple host trials simultaneously has been shown to be possible. Study registration SWAT repository https://www.qub.ac.uk/sites/TheNorthernIrelandNetworkforTrialsMethodologyResearch/FileStore/Filetoupload,846275,en.pdf#search=SWAT%2082 .

scholarly journals Completeness of reporting of randomised controlled trials including people with transient ischaemic attack or stroke: A systematic review

2018 ◽  
Vol 3 (4) ◽  
pp. 337-346 ◽  
Author(s):  
Blair Wilson ◽  
Peter Burnett ◽  
David Moher ◽  
Douglas G Altman ◽  
Rustam Al-Shahi Salman
Keyword(s):  
Systematic Review ◽  
Randomised Controlled Trial ◽  
Randomised Controlled Trials ◽  
Controlled Trial ◽  
Reporting Guidelines ◽  
Controlled Trials ◽  
Ischaemic Attack ◽  
Randomised Controlled ◽  
Over Time ◽  
Completeness Of Reporting

Purpose To assess the adherence of stroke randomised controlled trials to Consolidated Standards Of Reporting Trials reporting guidelines and investigate the factors that are associated with completeness of reporting. Method We took a random sample from the Cochrane Stroke Group's Trial Register of transient ischaemic attack or stroke randomised controlled trials, published in English in 1997–2016 inclusive. Two reviewers assessed the published report of the final primary results of stroke randomised controlled trials with a 10-point truncated Consolidated Standards Of Reporting Trials reporting checklist to investigate adherence over time, univariable associations and independent associations with total Consolidated Standards Of Reporting Trials reporting score in a multiple linear regression model. Findings In this random sample of 177 stroke randomised controlled trials, the mean score on the truncated Consolidated Standards Of Reporting Trials checklist was 5.8 (SD 2.2); reporting improved from 1997–2000 (4.9 SD 2.0) to 2001–2009 (5.8 SD 2.1) and to 2010–2016 (6.8 SD 2.1). A higher Consolidated Standards Of Reporting Trials score was independently associated with publication during epochs following a revision of Consolidated Standards Of Reporting Trials reporting guidelines (p < 0.001), journal endorsement of the Consolidated Standards Of Reporting Trials reporting guideline at the time of randomised controlled trial publication (p < 0.001) and modified journal impact factor using median citation distribution (p = 0.012). Discussion Stroke randomised controlled trial reporting to Consolidated Standards Of Reporting Trials standards has improved over time, but could be better. Conclusion Journal endorsement and enforcement of Consolidated Standards Of Reporting Trials reporting guidelines could further improve the reporting of stroke randomised controlled trials. Systematic review registration: Registered with PROSPERO (CRD42017072193).

scholarly journals Patient preference randomised controlled trials in mental health research

2006 ◽  
Vol 188 (4) ◽  
pp. 303-304 ◽  
Author(s):  
Louise Howard ◽  
Graham Thornicroft
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Patient Preference ◽  
Randomised Controlled Trials ◽  
Psychiatric Patients ◽  
Controlled Trial ◽  
Mental Health Research ◽  
Controlled Trials ◽  
Randomised Controlled ◽  
The Relationship

SummaryThe relationship between psychiatric patients' preferences for different treatments and the outcome of interventions is unclear, as the few relevant trials have tended to be underpowered. Strong patient preferences result in patients refusing to enter a trial. This leads to bias and limits generalisability, and the patient preference randomised controlled trial (RCT) design has been proposed as an alternative. Limitations and advantages of patient preference RCTs are discussed.

scholarly journals Using pens as an incentive for trial recruitment of older adults: An embedded randomised controlled trial

F1000Research ◽  
2019 ◽  
Vol 8 ◽  
pp. 315 ◽  
Author(s):  
Katie Whiteside ◽  
Lydia Flett ◽  
Alex Mitchell ◽  
Caroline Fairhurst ◽  
Sarah Cockayne ◽  
...  
Keyword(s):  
Older Adults ◽  
Randomised Controlled Trial ◽  
Randomised Controlled Trials ◽  
Controlled Trial ◽  
Falls Prevention ◽  
Controlled Trials ◽  
Return Rates ◽  
Link Type ◽  
Secondary Outcomes ◽  
Randomised Controlled

Background: Meeting recruitment targets for randomised controlled trials is challenging.  This trial evaluated the effectiveness of including a pen within the trial invitation pack on the recruitment of older adults into a randomised controlled trial. Methods: This trial was embedded within the Occupational Therapist Intervention Study, a falls-prevention randomised controlled trial.  Potential participants (n = 1862), who were posted an invitation pack from two General Practitioner practices, were randomised to either not receive a pen (n = 1295) or receive a pen (n = 648) with their invitation pack, using a 2:1 ratio.  The primary outcome was the likelihood of being randomised, and therefore fully recruited, to the host trial.  To be randomised to the host trial, participants had to: return a consent form and screening form; be eligible on their screening form; and return a baseline questionnaire and a monthly falls calendar.  Secondary outcomes were: the likelihood of returning (and time to return) a screening form; being eligible for the host trial; and remaining in the trial for at least 3 months. Results: The likelihood of being randomised to the host trial did not differ between the pen group (4.5%) and no pen group (4.3%; odds ratio 1.04; 95% confidence interval: 0.65 to 1.67; p = 0.86).  There were marginal differences in secondary outcomes in favour of the pen group, particularly in screening form return rates, though these differences were not statistically significant. Conclusion: Pens may not be an effective incentive for the recruitment of older adults into randomised controlled trials, though future trials are required. Registration: ISRCTN22202133; SWAT 37.

scholarly journals Non-strategic ignorance: Considering the potential for a paradigm shift in evidence-based mental health

2018 ◽  
Vol 24 (1) ◽  
pp. 3-20 ◽  
Author(s):  
Susan McPherson ◽  
Felicitas Rost ◽  
Sukhjit Sidhu ◽  
Maxine Dennis
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Randomised Controlled Trials ◽  
Controlled Trial ◽  
Cost Effective ◽  
Controlled Trials ◽  
Evidence Based ◽  
New Paradigm ◽  
Randomised Controlled ◽  
Strategic Ignorance

Randomised controlled trials form a central building block within the prevailing evidence-based mental health paradigm. Both methodology and paradigm have been widely problematised since their emergence in the mid-late twentieth century. We draw on the concept of ‘strategic ignorance’ to understand why the paradigm still prevails. We present focus group data gathered from 37 participants (service users, public, carers, general practitioners, commissioners) concerning the way they made sense of a randomised controlled trial of psychotherapy for treatment-resistant depression. Thematic analysis of the findings revealed an overall critique of randomised controlled trial methods which we refer to as ‘non-strategic ignorance’. Specifically, participants problematised the construct of depression, unseating the premise of the randomised controlled trial; they were sceptical about the purpose and highlighted its failure to show how therapy works or who might benefit; the randomised controlled trial was seen as inadequate for informing decisions about how to select a therapy. Participants assumed the treatment would be cost-effective given the client group and nature of the therapy, irrespective of any randomised controlled trial findings. Each area of lay (‘non-strategic’) critique has an analogous form within the methodological expert domain. We argue that ‘expert’ critiques have generally failed to have paradigmatic impact because they represent strategic ignorance. Yet parallel non-strategic critiques have common sense appeal, highlighting the potential power of lay voices. The discussion considers whether the evidence-based mental health paradigm is faced with epistemological problems of such complexity that the conditions exist for a new paradigm in which service user views are central and randomised controlled trials peripheral.

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.

A Comparison of Traditional Digital Blocks and Single Subcutaneous Palmar Injection Blocks at the Base of the Finger and a Meta-Analysis of the Digital Block Trials

2006 ◽  
Vol 31 (5) ◽  
pp. 547-555 ◽  
Author(s):  
Z. G. YIN ◽  
J. B. ZHANG ◽  
S. L. KAN ◽  
P. WANG
Keyword(s):  
Randomised Controlled Trials ◽  
Controlled Trial ◽  
Meta Analysis ◽  
Proximal Phalanx ◽  
Injection Pain ◽  
Controlled Trials ◽  
Current Trial ◽  
Randomised Controlled ◽  
Double Blinded ◽  
Digital Block

A randomised, double-blinded, controlled trial was performed to compare traditional digital blocks with single subcutaneous palmar injection blocks at the base of the finger. A search for randomised controlled trials of digital blocks through MEDLINE, EMBASE, Cochrane Controlled Trials Register and CBM was conducted and a meta-analysis including the current trial was performed. The current trial showed no difference between traditional digital blocks and single subcutaneous palmar injection bocks at the base of the finger in respect of injection pain and time to anaesthesia. The meta-analysis suggests that traditional digital blocks and single subcutaneous palmar injection blocks are similar with regard to injection pain and are less painful than the transthecal digital block. The palmar techniques, including single subcutaneous palmar block and transthecal block, carry a risk of not anaesthetising the dorsum of the digit adequately, particularly the dorsum of the thumb and the proximal phalanx of the fingers.

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