3.29 The CLL Literature is Continuing to Grow But We Need to Enter More Patients into Randomised Controlled Trials (RCTs) to Improve Our Evidence Base

Methods of extrication and spinal immobilisation following trauma remains controversial. There is a consensus shift towards encouraging patients to self-extricate from vehicles after collisions and reduced use of hard cervical collars. Difficulties in conducting randomised controlled trials in this area means that case reports are important in adding to the existing evidence base. This case of an 81-year-old female polytrauma patient suggests that self-extrication, and not using hard cervical collars is safe practice, even in the context of significant multi-level spinal injuries.

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Efficacy of atypical v. typical antipsychotics in the treatment of early psychosis: meta-analysis

The British Journal of Psychiatry ◽

10.1192/bjp.bp.109.066217 ◽

2010 ◽

Vol 196 (6) ◽

pp. 434-439 ◽

Cited By ~ 83

Author(s):

Nicolas A. Crossley ◽

Miguel Constante ◽

Philip McGuire ◽

Paddy Power

Keyword(s):

Side Effects ◽

Randomised Controlled Trials ◽

Atypical Antipsychotics ◽

Meta Analysis ◽

Evidence Base ◽

First Episode ◽

Controlled Trials ◽

Extrapyramidal Side Effects ◽

Randomised Controlled ◽

Typical Antipsychotics

BackgroundThere is an ongoing debate about the use of atypical antipsychotics as a first-line treatment for first-episode psychosis.AimsTo examine the evidence base for this recommendation.MethodMeta-analyses of randomised controlled trials in the early phase of psychosis, looking at long-term discontinuation rates, short-term symptom changes, weight gain and extrapyramidal side-effects. Trials were identified using a combination of electronic (Cochrane Central, EMBASE, MEDLINE and PsycINFO) and manual searches.ResultsFifteen randomised controlled trials with a total of 2522 participants were included. No significant differences between atypical and typical drugs were found for discontinuation rates (odds ratio (OR) = 0.7, 95% CI 0.4 to 1.2) or effect on symptoms (standardised mean difference (SMD) = –0.1, 95% CI –0.2 to 0.02). Participants on atypical antipsychotics gained 2.1 kg (95% CI 0.1 to 4.1) more weight than those on typicals, whereas those on typicals experienced more extrapyramidal side-effects (SMD = –0.4, 95% CI –0.5 to –0.2).ConclusionsThere was no evidence for differences in efficacy between atypical and typical antipsychotics, but there was a clear difference in the side-effect profile.

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Misrepresenting community treatment orders

Australasian Psychiatry ◽

10.1177/1039856217726699 ◽

2017 ◽

Vol 26 (1) ◽

pp. 38-40 ◽

Cited By ~ 3

Author(s):

John Little

Keyword(s):

Selection Bias ◽

Randomised Controlled Trials ◽

Evidence Base ◽

Community Treatment ◽

Controlled Trials ◽

Community Treatment Orders ◽

Randomised Controlled ◽

Meta Analyses ◽

Treatment Order ◽

Community Treatment Order

Objectives: To explore a contradiction between evidence suggesting community treatment order (CTO) ineffectiveness and clinical experience. Conclusions: The literature pertaining to CTOs actually provides an evidence base for both positions. The headline that three randomised controlled trials and subsequent meta-analyses fail to demonstrate significant differences between groups reflects selection bias. A case may still be made for CTOs.

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Psychological treatments in intellectual disability: the challenges of building a good evidence base

The British Journal of Psychiatry ◽

10.1192/bjp.bp.110.085084 ◽

2011 ◽

Vol 198 (6) ◽

pp. 428-430 ◽

Cited By ~ 29

Author(s):

Sabyasachi Bhaumik ◽

Satheesh Gangadharan ◽

Avinash Hiremath ◽

Paul Swamidhas Sudhakar Russell

Keyword(s):

Randomised Controlled Trials ◽

Evidence Base ◽

Good Evidence ◽

Current Evidence ◽

Controlled Trials ◽

Psychological Treatments ◽

Current Evidence Base ◽

People With Intellectual Disabilities ◽

Randomised Controlled ◽

The Cost

SummaryPsychological treatments are widely used for the management of mental health and behavioural problems in people with intellectual disabilities. The evidence base, including the cost-effectiveness of such interventions, is limited. This editorial explores the current evidence base and analyses its strengths and limitations. The editorial also highlights current problems in conducting randomised controlled trials in this area and suggests a way forward.

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New Evidence in the Booming Field of Online Mindfulness: An Updated Meta-Analysis of Randomised Controlled Trials (Preprint)

10.2196/preprints.28168 ◽

2021 ◽

Author(s):

Marion Sommers-Spijkerman ◽

Judith Austin ◽

Ernst Bohlmeijer ◽

Wendy Pots

Keyword(s):

Mental Health ◽

Randomised Controlled Trials ◽

Meta Analysis ◽

Well Being ◽

Evidence Base ◽

Effect Sizes ◽

Controlled Trials ◽

Long Term Follow Up ◽

Randomised Controlled

BACKGROUND There is a need for regularly updating the evidence base on the effectiveness of online mindfulness-based interventions (MBIs), especially considering how fast this field is growing and developing. OBJECTIVE The current study presents an updated meta-analysis of randomised controlled trials assessing the effects of online MBIs on mental health, as well as the potential moderators of those effects. METHODS A systematic literature search was conducted in PsycINFO, PubMed and Web of Science up to July 19th, 2019. Seventy trials totalling 91 comparisons were included. Pre-to-post and pre-to-follow-up between-group effect sizes (Hedges’ g) were calculated for depression, anxiety, stress, well-being and mindfulness, using a random effects model. RESULTS The findings revealed statistically significant moderate pre-to-post effects on stress (g=0.41) and mindfulness (g=0.43) and small effects on depression (g=0.31) and anxiety (g=0.23). For well-being, a significant effect was found only when omitting low quality studies (g=0.34). Significant but small follow-up effects were found for depression (g=0.25), anxiety (g=0.17) and stress (g=-0.11). Subgroup analyses revealed that online MBIs resulted in higher effect sizes for stress when offered with guidance. For stress and mindfulness, studies that used an inactive control condition yielded larger effects. CONCLUSIONS Our findings do not only demonstrate that the field of online MBIs is booming, but also corroborate previous evidence that online MBIs are beneficial for improving mental health outcomes in a broad range of samples. To advance the field of online MBIs, future trials should pay specific attention to methodological quality, adherence and long-term follow-up measurements.

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Evidence base for medicines over-reliant on expensive randomised controlled trials, says MHRA chair

The Pharmaceutical Journal ◽

10.1211/pj.2015.20069465 ◽

2015 ◽

Keyword(s):

Randomised Controlled Trials ◽

Evidence Base ◽

Controlled Trials ◽

Randomised Controlled

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Evidence-Based Acupuncture? a Challenge Ahead

Asian Medicine ◽

10.1163/157342105777996755 ◽

2005 ◽

Vol 1 (1) ◽

pp. 147-161 ◽

Cited By ~ 2

Author(s):

Hugh MacPherson

Keyword(s):

Therapeutic Relationship ◽

Complex Intervention ◽

Trial Design ◽

Randomised Controlled Trials ◽

Evidence Base ◽

Controlled Trials ◽

Evidence Based ◽

Central Theme ◽

Outcomes Measures ◽

Randomised Controlled

Acupuncture's increasingly widespread use has been paralleled by calls for more rigorous evidence of its effectiveness. In this article, some of the challenges of developing a strong evidence base are explored. As acupuncture is a complex intervention, a case is made for the appropriateness and relevance of pragmatic rather than experimental randomised controlled trials in the evaluation of acupuncture. Within this context there remain key challenges associated with ensuring treatment within a trial is sufficiently flexible, so that it can match the expected variability in patients, that outcomes measures capture the broader range of changes that can be experienced by patients, and that the therapeutic relationship is not compromised by the trial design. The central theme is the importance of protecting the integrity of the acupuncture, and the underlying principles upon which it is based.

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A mapping review of sacrococcygeal pilonidal sinus disease

Techniques in Coloproctology ◽

10.1007/s10151-021-02432-9 ◽

2021 ◽

Author(s):

M. Kumar ◽

W. H. Clay ◽

M. J. Lee ◽

S. R. Brown ◽

D. Hind

Keyword(s):

Surgical Treatment ◽

Systematic Reviews ◽

Pilonidal Sinus ◽

Randomised Controlled Trials ◽

Wound Care ◽

Surgical Techniques ◽

Evidence Base ◽

Controlled Trials ◽

Mapping Review ◽

Randomised Controlled

Abstract Background Pilonidal sinus is a hole in the natal cleft which may cause severe pain and become infected. The evidence base for management of pilonidal sinus is said to be poor quality, poorly focused and rapidly proliferating. We undertook a systematic mapping review to provide a broad overview of the field and support the identification of research priorities. Methods We searched MEDLINE, CINAHL, and EMBASE from inception to 22nd Nov 2020 for primary research studies focused on the management of pilonidal sinus. We extracted data on study design and categorised studies under five major headings (‘non-surgical treatment’, ‘surgical treatment’, ‘aftercare’ and ‘other’), producing frequency counts for different study designs. Gaps in research were identified from published systematic reviews and tabulated. Results We identified 983 eligible studies, of which 36 were systematic reviews and/or meta-analyses; 121 were randomised controlled trials), and 826 observational studies of various design. The majority of studies evaluated surgical techniques (n = 665), or adjuvant medical interventions (n = 98). The literature on wound care has developed most recently, and the evidence base includes 30% randomised controlled trials. Gaps analysis highlighted comparison of surgical techniques including flaps, laser depilation, and wound care interventions as potential areas for randomised controlled trials. Conclusions This mapping review summarises eight decades of research on the management of pilonidal sinus. Further research is needed to identify front-running interventions, understand variation in practice and patient values, and to prioritise future research.

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A Systematic Review to Assess the Effectiveness of Technology-Based Interventions to Address Obesity in Children

10.21203/rs.2.11016/v1 ◽

2019 ◽

Author(s):

Megan McMullan ◽

Rachel Millar ◽

Jayne Woodside

Keyword(s):

Systematic Review ◽

Childhood Obesity ◽

Secondary Prevention ◽

Randomised Controlled Trials ◽

English Language ◽

Evidence Base ◽

Controlled Trials ◽

Obese Children ◽

Active Video ◽

Randomised Controlled

Abstract Background: Childhood obesity is associated with a multitude of co-morbidities, including hypertension, hyperlipidaemia, cardiovascular disease and type 2 diabetes. Childhood obesity can also affect a young person’s social, emotional and mental health if they encounter negative prejudice and social marginalisation. Given the prevalence of overweight and obese children globally, it is imperative that effective interventions are developed. Children are receptive to information conveyed via digital means, therefore, the use of technology may play a crucial role in interventions to reduce childhood obesity. This systematic review aimed to review and critically appraise the literature published to date in relation to the effectiveness of technology-based interventions, employed as secondary prevention, in addressing childhood obesity. Methods: An electronic search strategy was undertaken in Medline and Embase, covering publications up to and including 12th July 2018. Randomised controlled trials assessing the effectiveness of technology-based interventions on weight-related outcomes in children, aged 8 to 18, published only in the English language, were included. Results: From an initial search total of 1,012 studies, 11 met the inclusion criteria. They were assessed for methodological quality using the Cochrane Risk of Bias Tool for Randomised Controlled Trials and were analysed using a narrative approach. The findings of this review showed a weak evidence base regarding the role of technology-based interventions, employed as secondary prevention, to address childhood obesity. Of the eleven studies reviewed, three (27%) showed a positive relationship between technology-based interventions and weight-related outcomes in overweight or obese children. Conclusions: This review suggests that technology-based interventions, primarily active video games, as well as internet or web-based interventions and mobile phone communications, may, with further research, have the potential to impact positively on weight-related outcomes. It is difficult to determine the degree of efficacy of these technology-based interventions, as only two databases were searched, selecting only English language articles. Moreover, the included studies demonstrated a lack of high-quality evidence. The lack and heterogeneity of studies with technology-based interventions is a further limitation.

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