scholarly journals Effectiveness of hospital clowns for symptom management in paediatrics: systematic review of randomised and non-randomised controlled trials

BMJ ◽  
2020 ◽  
pp. m4290
Author(s):  
Luís Carlos Lopes-Júnior ◽  
Emiliana Bomfim ◽  
Karin Olson ◽  
Eliane Tatsch Neves ◽  
Denise Sayuri Calheiros Silveira ◽  
...  

Abstract Objective To evaluate evidence from randomised controlled trials and non-randomised controlled trials on the effectiveness of hospital clowns for a range of symptom clusters in children and adolescents admitted to hospital with acute and chronic conditions. Design Systematic review of randomised and non-randomised controlled trials. Data sources Medline, ISI of Knowledge, Cochrane Central Register of Controlled Trials, Science Direct, Scopus, American Psychological Association PsycINFO, Cumulative Index to Nursing and Allied Health Literature, and Latin American and Caribbean Health Sciences Literature. Study selection Randomised and non-randomised controlled trials were peer reviewed using the following eligibility criteria: children and adolescents who were admitted to hospital for acute conditions or chronic disorders, studies comparing use of hospital clowns with standard care, and studies evaluating the effect of hospital clowns on symptom management of inpatient children and adolescents as a primary outcome. Data extraction and synthesis Two investigators independently screened studies, extracted data, and appraised the risk of bias. Methodological appraisal was assessed by two investigators independently using the Jadad scale, the revised Cochrane risk-of-bias tool for randomised controlled trials (RoB 2), and the risk of bias in non-randomised studies (ROBINS-I) tool for non-randomised controlled trials. Results 24 studies (n=1612) met the inclusion criteria for data extraction and analysis. Most studies were randomised controlled trials (n=13). Anxiety was the most frequently analysed symptom (n=13), followed by pain (n=9), psychological and emotional responses and perceived wellbeing (n=4), stress (n=4), cancer related fatigue (n=3), and crying (n=2). Five studies used biomarkers, mainly cortisol, to assess stress or fatigue outcome following hospital clowns. Most of the randomised controlled trials (n=11; 85%) were rated as showing some concerns, and two trials were rated with a high risk of bias. Most non-randomised controlled trials (n=6; 55%) were rated with a moderate risk of bias according to ROBINS-I tool. Studies showed that children and adolescents who were in the presence of hospital clowns, either with or without a parent present, reported significantly less anxiety during a range of medical procedures, as well as improved psychological adjustment (P<0.05). Three studies that evaluated chronic conditions showed favourable results for the intervention of hospital clowns with significant reduction in stress, fatigue, pain, and distress (P<0.05). Conclusions These findings suggest that the presence of hospital clowns during medical procedures, induction of anaesthesia in the preoperative room, and as part of routine care for chronic conditions might be a beneficial strategy to manage some symptom clusters. Furthermore, hospital clowns might help improve psychological wellbeing in admitted children and adolescents with acute and chronic disorders, compared with those who received only standard care. Systematic review registration PROSPERO CRD42018107099.

2021 ◽  
pp. 146531252110560
Author(s):  
Nidhi P Parmar ◽  
Gabrielle L Thompson ◽  
Nikki E Atack ◽  
Anthony J Ireland ◽  
Martyn Sherriff ◽  
...  

Background: Decalcification and gingivitis caused by plaque accumulation around brackets are common iatrogenic effects of fixed appliances. The influence of conventional versus self-ligating bracket design on microbial colonisation is unknown. Objective: To assess the levels of microbial colonisation associated with conventional and self-ligating brackets. Search sources: Three databases were searched for publications from 2009 to 2021. Data selection: Randomised controlled trials comparing levels of microbial colonisation before and during treatment with conventional and self-ligating brackets were assessed independently and in duplicate. Data extraction: Data were extracted independently by two authors from the studies that fulfilled the inclusion criteria. Risk of bias assessments were made using the revised Cochrane risk of bias tool for randomized trials. The quality of the included studies was assessed using the Critical Appraisal Skills Programme Checklist. Results: A total of 11 randomised controlled trials were included in this systematic review. Six of the studies were found to be at low risk of bias and five presented with some concerns. The studies were considered moderate to high quality. Five trials reported no statistically significant difference in microbial colonisation between bracket types. The remaining studies showed mixed results, with some reporting increased colonisation of conventional brackets and others increased colonisation of self-ligating brackets. The heterogeneity of study methods and outcomes precluded meta-analysis. Conclusion: Of the 11 studies included in this systematic review, five found no differences in colonisation between conventional and self-ligating brackets. The remaining studies showed mixed results. The evidence is inconclusive regarding the association between bracket design and levels of microbial colonisation.


2021 ◽  
Vol 5 (1) ◽  
pp. e001129
Author(s):  
Bill Stevenson ◽  
Wubshet Tesfaye ◽  
Julia Christenson ◽  
Cynthia Mathew ◽  
Solomon Abrha ◽  
...  

BackgroundHead lice infestation is a major public health problem around the globe. Its treatment is challenging due to product failures resulting from rapidly emerging resistance to existing treatments, incorrect treatment applications and misdiagnosis. Various head lice treatments with different mechanism of action have been developed and explored over the years, with limited report on systematic assessments of their efficacy and safety. This work aims to present a robust evidence summarising the interventions used in head lice.MethodThis is a systematic review and network meta-analysis which will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses statement for network meta-analyses. Selected databases, including PubMed, Embase, MEDLINE, Web of Science, CINAHL and Cochrane Central Register of Controlled Trials will be systematically searched for randomised controlled trials exploring head lice treatments. Searches will be limited to trials published in English from database inception till 2021. Grey literature will be identified through Open Grey, AHRQ, Grey Literature Report, Grey Matters, ClinicalTrials.gov, WHO International Clinical Trials Registry and International Standard Randomised Controlled Trials Number registry. Additional studies will be sought from reference lists of included studies. Study screening, selection, data extraction and assessment of methodological quality will be undertaken by two independent reviewers, with disagreements resolved via a third reviewer. The primary outcome measure is the relative risk of cure at 7 and 14 days postinitial treatment. Secondary outcome measures may include adverse drug events, ovicidal activity, treatment compliance and acceptability, and reinfestation. Information from direct and indirect evidence will be used to generate the effect sizes (relative risk) to compare the efficacy and safety of individual head lice treatments against a common comparator (placebo and/or permethrin). Risk of bias assessment will be undertaken by two independent reviewers using the Cochrane Risk of Bias tool and the certainty of evidence assessed using the Grading of Recommendations, Assessment, Development and Evaluations guideline for network meta-analysis. All quantitative analyses will be conducted using STATA V.16.DiscussionThe evidence generated from this systematic review and meta-analysis is intended for use in evidence-driven treatment of head lice infestations and will be instrumental in informing health professionals, public health practitioners and policy-makers.PROSPERO registration numberCRD42017073375.


2021 ◽  
pp. 1-13
Author(s):  
Davide Papola ◽  
Giovanni Ostuzzi ◽  
Federico Tedeschi ◽  
Chiara Gastaldon ◽  
Marianna Purgato ◽  
...  

Background Psychotherapies are the treatment of choice for panic disorder, but which should be considered as first-line treatment is yet to be substantiated by evidence. Aims To examine the most effective and accepted psychotherapy for the acute phase of panic disorder with or without agoraphobia via a network meta-analysis. Method We conducted a systematic review and network meta-analysis of randomised controlled trials (RCTs) to examine the most effective and accepted psychotherapy for the acute phase of panic disorder. We searched MEDLINE, Embase, PsycInfo and CENTRAL, from inception to 1 Jan 2021 for RCTs. Cochrane and PRISMA guidelines were used. Pairwise and network meta-analyses were conducted using a random-effects model. Confidence in the evidence was assessed using Confidence in Network Meta-Analysis (CINeMA). The protocol was published in a peer-reviewed journal and in PROSPERO (CRD42020206258). Results We included 136 RCTs in the systematic review. Taking into consideration efficacy (7352 participants), acceptability (6862 participants) and the CINeMA confidence in evidence appraisal, the best interventions in comparison with treatment as usual (TAU) were cognitive–behavioural therapy (CBT) (for efficacy: standardised mean differences s.m.d. = −0.67, 95% CI −0.95 to −0.39; CINeMA: moderate; for acceptability: relative risk RR = 1.21, 95% CI −0.94 to 1.56; CINeMA: moderate) and short-term psychodynamic therapy (for efficacy: s.m.d. = −0.61, 95% CI −1.15 to −0.07; CINeMA: low; for acceptability: RR = 0.92, 95% CI 0.54–1.54; CINeMA: moderate). After removing RCTs at high risk of bias only CBT remained more efficacious than TAU. Conclusions CBT and short-term psychodynamic therapy are reasonable first-line choices. Studies with high risk of bias tend to inflate the overall efficacy of treatments. Results from this systematic review and network meta-analysis should inform clinicians and guidelines.


2020 ◽  
Vol 76 (12) ◽  
pp. 1639-1651
Author(s):  
John P. Thomas ◽  
Yoon K. Loke ◽  
Leo Alexandre

Abstract Purpose A growing body of preclinical and observational research suggests that statins have potential as a therapeutic strategy in patients with cancer. This systematic review of randomised controlled trials (RCTs) in patients with solid tumours aimed to determine the efficacy of statin therapy on mortality outcomes, their safety profile and the risk of bias of included studies. Methods Full-text articles comparing statin therapy versus control in solid tumours and reporting mortality outcomes were identified from Medline and Embase from conception to February 2020. A systematic review with qualitative (primarily) and quantitative synthesis was conducted. This systematic review was prospectively registered (Prospero registration CRD42018116364). Results Eleven trials of 2165 patients were included. Primary tumour sites investigated included lung, colorectal, gastro-oesophageal, pancreatic and liver. Most trials recruited patients with advanced malignancy and used sub-maximal statin doses for relatively short durations. Aside from one trial which demonstrated benefit with allocation to pravastatin 40 mg in hepatocellular carcinoma, the remaining ten trials did not demonstrate efficacy with statins. The pooled hazard ratio for all-cause mortality with allocation to pravastatin in patients with hepatocellular carcinoma in two trials was 0.69 (95% confidence interval CI 0.30–1.61). Study estimates were imprecise. There were no clinically important differences in statin-related adverse events between groups. Overall, included trials were deemed low risk of bias. Conclusion The trial evidence is not sufficiently robust to confirm or refute the efficacy and safety of statins in patients with solid malignant tumours. Study and patient characteristics may explain this uncertainty. The potential role of high-dose statins in adjuvant settings deserves further research.


2019 ◽  
Vol 48 (4) ◽  
pp. 489-497 ◽  
Author(s):  
K J Sheehan ◽  
L Fitzgerald ◽  
S Hatherley ◽  
C Potter ◽  
S Ayis ◽  
...  

Abstract Objective to determine the extent to which equity factors contributed to eligibility criteria of trials of rehabilitation interventions after hip fracture. We define equity factors as those that stratify healthcare opportunities and outcomes. Design systematic search of MEDLINE, Embase, CINHAL, PEDro, Open Grey, BASE and ClinicalTrials.gov for randomised controlled trials of rehabilitation interventions after hip fracture published between 1 January 2008 and 30 May 2018. Trials not published in English, secondary prevention or new models of service delivery (e.g. orthogeriatric care pathway) were excluded. Duplicate screening for eligibility, risk of bias (Cochrane Risk of Bias Tool) and data extraction (Cochrane’s PROGRESS-Plus framework). Results twenty-three published, eight protocol, four registered ongoing randomised controlled trials (4,449 participants) were identified. A total of 69 equity factors contributed to eligibility criteria of the 35 trials. For more than 50% of trials, potential participants were excluded based on residency in a nursing home, cognitive impairment, mobility/functional impairment, minimum age and/or non-surgical candidacy. Where reported, this equated to the exclusion of 2,383 out of 8,736 (27.3%) potential participants based on equity factors. Residency in a nursing home and cognitive impairment were the main drivers of these exclusions. Conclusion the generalisability of trial results to the underlying population of frail older adults is limited. Yet, this is the evidence base underpinning current service design. Future trials should include participants with cognitive impairment and those admitted from nursing homes. For those excluded, an evidence-informed reasoning for the exclusion should be explicitly stated. PROSPERO CRD42018085930.


2016 ◽  
Vol 34 (2) ◽  
pp. 76-83 ◽  
Author(s):  
Yan Yang ◽  
Qinghui Que ◽  
Xiaode Ye ◽  
Guo hua Zheng

Background Manual acupuncture (MA) is commonly used as a treatment for migraine in China. However, its specific clinical effects have been challenged on the basis that some of its effects may relate to psychological or ‘placebo’ mechanisms. Objective To identify the effectiveness of verum MA compared with sham acupuncture for the treatment of migraine. Methods Eight electronic databases were searched for randomised controlled trials (RCTs) evaluating the effect of verum versus sham MA on migraine. The quality of included trials was assessed using the ‘risk of bias’ tool provided by the Cochrane Handbook for Systematic Review of Intervention. RevMan 5.2 software was used for data analysis. Results Ten trials with 997 participants were included. Most trials had high methodological quality and were at low risk of bias. Meta-analysis showed superior effects of verum MA over sham acupuncture on the total effective rate, reflected by a reduction in the ‘not effective’ rate (relative risk (RR) 0.24, 95% CI 0.15 to 0.38; p<0.0001, four trials) and a reduced recurrence rate (RR 0.47, 95% CI 0.28 to 0.81; p=0.006, two trials), but no significant differences in headache intensity, frequency or duration, accompanying symptoms and use of medication. No severe adverse events related to acupuncture occurred during treatment with either verum or sham MA. Conclusions Current clinical evidence suggests that verum acupuncture is superior to sham acupuncture in migraine, reflected by a higher total effective rate and decreased recurrence rate. Nevertheless, further large-scale RCTs with a rigorous design are required to confirm these findings in view of the relative paucity of eligible RCTs and small sample sizes of those included.


2020 ◽  
Author(s):  
Blair Ross Hamilton ◽  
Katherine Staines ◽  
George Kelley ◽  
Kristi Kelley ◽  
Wendy Kohrt ◽  
...  

Introduction: Exercise is a cost-effective, widely available intervention that has been reported to help maintain optimal bone mineral density (BMD) in men, however, consideration of exercise modality is needed if the aim is to promote skeletal health. A previous meta-analysis of randomised controlled trials observed a moderate benefit on femoral neck (FN) but no benefit on lumbar spine (LS) BMD. However, since that analysis more randomised controlled trials (RCTs) have been published and updated methods of meta-analysis have been developed and therefore an updated systematic review and meta-analysis is required. Methods and analysis: RCTs of &gt;24 weeks and published in English up to 01/05/20 will be retrieved by searching 3 electronic databases, cross referencing and expert review. The primary outcome measures will be changes in FN and LS BMD and lower limb BMD. Risk of bias for each study will be assessed using the Cochrane Risk of Bias instrument for RCTs, while the strength of evidence for each outcome will be assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) instrument. Standardised effect sizes will be calculated from each study and pooled using the inverse heterogeneity (IVhet) model. Trial Registration number: CRD42020180441.


BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e046599
Author(s):  
Diana Naehrig ◽  
Aaron Schokman ◽  
Jessica Kate Hughes ◽  
Ronald Epstein ◽  
Ian B Hickie ◽  
...  

ObjectivesClinician well-being has been recognised as an important pillar of healthcare. However, research mainly addresses mitigating the negative aspects of stress or burnout, rather than enabling positive aspects. With the added strain of a pandemic, identifying how best to maintain and support the well-being, satisfaction and flourishing of general practitioners (GPs) is now more important than ever.DesignSystematic review.Data sourcesWe searched MEDLINE, PsycINFO, Embase, CINAHL and Scopus from 2000 to 2020.Study selectionIntervention studies with more than 50% GPs in the sample evaluating self-reported well-being, satisfaction and related positive outcomes were included. The Cochrane Risk of Bias 2 tool was applied.ResultsWe retrieved 14 792 records, 94 studies underwent full-text review. We included 19 studies in total. Six randomised controlled trials, three non-randomised, controlled trials, eight non-controlled studies of individual or organisational interventions with a total of 1141 participants. There were two quasi-experimental articles evaluating health system policy change. Quantitative and qualitative positive outcomes were extracted and analysed. Individual mindfulness interventions were the most common (k=9) with medium to large within-group (0.37–1.05) and between-group (0.5–1.5) effect sizes for mindfulness outcomes, and small-to-medium effect sizes for other positive outcomes including resilience, compassion and empathy. Studies assessing other intervention foci or other positive outcomes (including well-being, satisfaction) were of limited size and quality.ConclusionsThere is remarkably little evidence on how to improve GPs well-being beyond using mindfulness interventions, particularly for interventions addressing organisational or system factors. This was further undermined by inconsistent reporting, and overall high risk of bias. We need to conduct research in this space with the same rigour with which we approach clinical intervention studies in patients.PROSPERO registration numberCRD42020164699.Funding sourceDr Diana Naehrig is funded through the Raymond Seidler PhD scholarship.


2021 ◽  
Author(s):  
Jack Birch ◽  
Rebecca Jones ◽  
Julia Mueller ◽  
Matthew McDonald ◽  
Rebecca Richards ◽  
...  

Background: It has been suggested that interventions focusing on individual behaviour change, such as behavioural weight management interventions, may exacerbate health inequalities. These intervention-generated inequalities may occur at different stages, including intervention uptake, adherence and effectiveness. We conducted a systematic review to synthesise evidence on how different measures of inequality moderate the uptake of, adherence to and effectiveness of behavioural weight management interventions in adults. Methods: We updated a previous systematic literature review from the US Preventive Services Taskforce to identify trials of behavioural weight management interventions in adults that could be conducted in or recruited from primary care. Medline, Cochrane database (CENTRAL) and PsycINFO were searched. Only randomised controlled trials and cluster-randomised controlled trials were included. Two investigators independently screened articles for eligibility and conducted risk of bias assessment. We curated publication families for eligible trials. The PROGRESS-Plus acronym (place of residence, race/ethnicity, occupation, gender, religion, education, socioeconomic status, social capital, plus other discriminating factors) was used to consider a comprehensive range of health inequalities. Data on trial uptake, intervention adherence, weight change, and PROGRESS-Plus related-data were extracted. Results: Data extraction in currently underway. A total of 108 studies are included in the review. Data will be synthesised narratively and through the use of Harvest Plots. A Harvest plot for each PROGRESS-Plus criterion will be presented, showing whether each trial found a negative, positive or no health inequality gradient. We will also identify potential sources of unpublished original research data on these factors which can be synthesised through a future individual participant data meta- analysis. Conclusions and implications: The review findings will contribute towards the consideration of intervention-generated inequalities by researchers, policy makers and healthcare and public health practitioners. Authors of trials included in the completed systematic review may be invited to collaborate on a future IPD meta-analysis. PROSPERO registration number: CRD42020173242


Author(s):  
Ricardo Peralta ◽  
Luís Sousa ◽  
António Filipe Cristóvão

Background: Based on a literature review of various studies, comparisons between BH and RL are inconclusive regarding some outcomes. However, in the last 5 years, some studies have been published that may contribute to clarifying which cannulation technique (CT) allows better fistula survival. Aim: To review which cannulation technique allows better primary patency of the arteriovenous fistula in haemodialysis patients. Methods: We will include all randomised controlled trials and observational studies that include comparisons among CTs and thus define the benefits and risks of each CT. A PRISMA-compliant systematic review and meta-analysis will be performed in accordance with the quality and homogeneity of studies. A comprehensive search strategy will be applied to the CINAHL, MEDLINE and Embase electronic databases from January 2000 to September 2021. The primary outcome is the arteriovenous fistula primary patency. To assess the risk of bias in randomised controlled trials or quasi-experimental studies, we will use the tool Revised Cochrane Risk-of-Bias Tool for Randomized Trials (RoB 2). For nonrandomised studies, the Risk of Bias In Non-Randomized Studies of Interventions (ROBINS-I) will be used. Discussion: The evidence generated from this systematic review of current evidence could inform the design and implementation of continuous quality improvement programs in cannulation techniques in haemodialysis patients, as well as contributing to improving the curricula within haemodialysis courses. This protocol was registered with the National Institute for Health Research PROSPERO database prior to commencement (registration number CRD42021237050).


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