scholarly journals Status, reporting completeness and methodological quality of pilot randomised controlled trials in acupuncture: protocol for a systematic review

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e052528
Author(s):  
Yajun Zhang ◽  
Hantong Hu ◽  
Xiaoyu Li ◽  
Jiali Lou ◽  
Xiaofen He ◽  
...  
Keyword(s):  
Systematic Review ◽  
Methodological Quality ◽  
Randomised Controlled Trials ◽  
Biomedical Literature ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Publication Trends ◽  
Pilot Trials ◽  
Randomised Controlled

IntroductionTo date, there has been a lack of knowledge about the status, reporting completeness and methodological quality of pilot trials in the acupuncture field. Thus, this systematic review protocol aims to: (1) investigate publication trends and aspects of feasibility evaluated in acupuncture pilot trials; (2) identify the proportion of acupuncture pilot trials that lead to definitive trials and (3) assess the reporting completeness and methodological quality of pilot trials in acupuncture.Methods and analysisStudies of acupuncture pilot randomised controlled trials published from 2011 to 2021 will be retrieved in seven databases in January 2022, including PubMed, Web of Science, EMBASE, Cochrane Library, Chinese National Knowledge Infrastructure, Wanfang Database and Chinese Biomedical Literature Database. The methodological quality and reporting completeness of all included studies will be assessed using the risk of bias 2.0 tool (RoB 2) and the Consolidated Standards of Reporting Trials (CONSORT) extension to randomised pilot and feasibility trials, respectively. For the primary analysis, publication trends, aspects of feasibility and the proportion of pilot trials that lead to definitive trials will be analysed. A quantitative analysis of the methodological quality and reporting completeness of the included trials will be implemented by calculating the percentage of items reported in each domain of RoB 2 and CONSORT. The secondary analysis will adopt a regression analysis to identify factors associated with the reporting completeness.Ethics and disseminationEthical approval is not required for this study. This study is planned to be submitted to a peer-reviewed academic journal.

scholarly journals Methodological quality of randomised controlled trials in burns care. A systematic review

Burns ◽  
2009 ◽  
Vol 35 (7) ◽  
pp. 956-961 ◽  
Author(s):  
Stefan Danilla ◽  
Jason Wasiak ◽  
Susana Searle ◽  
Cristian Arriagada ◽  
Cesar Pedreros ◽  
...  
Keyword(s):  
Systematic Review ◽  
Methodological Quality ◽  
Randomised Controlled Trials ◽  
Controlled Trials ◽  
Randomised Controlled

scholarly journals Telerehabilitation Versus Standard Care for Improving Cognitive Function and Quality of Life for Adults with Traumatic Brain Injury: a Systematic Review

2018 ◽  
Author(s):  
Samantha Betts ◽  
Lana Feichter ◽  
Zoe Kleinig ◽  
Alice O'Connell-Debais ◽  
Henry Thai ◽  
...  
Keyword(s):  
Systematic Review ◽  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Methodological Quality ◽  
Randomised Controlled Trials ◽  
Critical Appraisal ◽  
Current Evidence ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Randomised Controlled

ABSTRACT Traumatic brain injury (TBI) is the most significant cause of death and severe disability following major trauma within Australia. Populations at risk include young adults aged 15 to 34, older adults, and military personnel. The main form of intervention following traumatic brain injury is rehabilitation, which places a large demand on the healthcare system. Telerehabilitation involves interventions delivered via telecommunication, which can improve accessibility and reduce this burden. There have been no systematic reviews conducted on the effectiveness of telerehabilitation in treating traumatic brain injury. Purpose: To examine the effectiveness of telerehabilitation for adults with traumatic brain injury. Methods: A systematic search of Medline, Embase, the Cumulative Index of Nursing and Allied Health Literature (CINAHL), Scopus, The Cochrane Library, OTSeeker and Google Scholar was conducted. Studies were included with participants aged 18 to 64 with traumatic brain injury and receiving telerehabilitation interventions. Methodological quality was assessed using the critical appraisal tools: Critical Appraisal Skills Programme (CASP) checklist for randomised controlled trials, and McMaster Critical Review for Quantitative Studies for non-randomised studies. Results: Three randomised controlled trials, one pseudo-randomised controlled trial, one case-control trial and one pre-post case series were included in this systematic review. Critical appraisal of the included studies revealed overall methodological quality to be moderate. A range of interventions with differing parameters were used as part of telerehabilitation. Collectively, there is some consistent evidence to indicate that telerehabilitation may be equally effective as other forms of care in the delivery of cognitive and psychological interventions, in addressing memory and depressive symptoms for adults with mild to severe traumatic brain injury. However, it is unclear if it is superior to other forms of care. Conclusions: A small number of studies have investigated the effect of telerehabilitation for adults with traumatic brain injury. The current evidence base is limited due to lack of standardised intervention parameters, outcomes measures and robust sample size. Despite these limitations, telerehabilitation may offer a complementary model of care for adults with traumatic brain injury, especially in instances where traditional models of care may not be readily accessible (such as those in rural and remote areas).

A systematic review of randomised controlled trials of psychosocial interventions for acute mental health inpatients

2021 ◽  
Vol 10 (3) ◽  
pp. 1-17
Author(s):  
Laura D Wainwright ◽  
Gillian Haddock ◽  
Charlotte Dunster-Page ◽  
Katherine Berry
Keyword(s):  
Quality Of Life ◽  
Methodological Quality ◽  
Randomised Controlled Trials ◽  
Social Care ◽  
Psychosocial Interventions ◽  
Controlled Trials ◽  
Patient Functioning ◽  
Electronic Search ◽  
Randomised Controlled

Background/Aims Inpatient wards provide an opportunity to intervene with medical, psychological and social care to contain distress and prevent future relapse. However, they have been criticised for an over-reliance on medication and risk management with limited psychosocial interventions. The aim of this study was to investigate clinical trials of psychosocial interventions for inpatients to identify interventions that are effective at improving quality of life, symptoms or patient functioning. Methods An electronic search of six databases was conducted for papers published from 1806 up until February 2017. A total of 18 randomised controlled trials was identified in which outcomes for symptoms, quality of life or functioning were reported. Results Overall, 15 trials showed a statistically significant result for at least one outcome. Seven categories were identified from the 18 studies, at least one in each category was found to be effective for symptoms, quality of life or functioning. The majority were effective (15 out of 18). Conclusions Given that the methodological quality was generally low and number of randomised controlled trials were small, it is difficult to draw definitive conclusions. Recommendations include more and repeated trials using rigorous methods of testing and reporting.

Acupuncture for Amnestic Mild Cognitive Impairment: A Meta-Analysis of Randomised Controlled Trials

2016 ◽  
Vol 34 (5) ◽  
pp. 342-348 ◽  
Author(s):  
Min Deng ◽  
Xu-Feng Wang
Keyword(s):  
Cognitive Impairment ◽  
Mild Cognitive Impairment ◽  
Methodological Quality ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Scientific Journal ◽  
Adjunctive Treatment ◽  
Controlled Trials ◽  
Randomised Controlled

Objective Mild cognitive impairment (MCI) is a pre-dementia state; 5–10% of cases per year will evolve into dementia. MCI can be amnestic (AMCI) or non-amnestic. AMCI is associated with a higher risk of progression. In recent years, interest in acupuncture as a potential treatment for AMCI has grown. The aim of this meta-analysis was to estimate the clinical effectiveness and safety of acupuncture for AMCI. Methods Randomised controlled trials (RCTs) of acupuncture versus medical treatment for AMCI were identified using the following databases from inception to July 2015: PubMed; Medline; CENTRAL; Chinese Scientific Journal Database; The Chinese Acupuncture Trials Register; China National Knowledge Infrastructure (CNKI); and Wanfang database. Data were extracted from RCTs meeting the inclusive criteria according to Cochrane methods. Meta-analyses were conducted using Rev Man V.5.3 software. Results Five trials involving 568 subjects were included. Meta-analysis showed that participants receiving acupuncture had better outcomes than those receiving nimodipine with greater clinical efficacy rates (odds ratio (OR) 1.78, 95% CI 1.19 to 2.65; p<0.01), mini-mental state examination (MMSE) scores (mean difference (MD) 0.99, 95% CI 0.71 to 1.28; p<0.01), and picture recognition score (MD 2.12, 95% CI 1.48 to 2.75; p<0.01). Meta-analysis also showed acupuncture in conjunction with nimodipine significantly improved MMSE scores (MD 1.09, 95% CI 0.29 to 1.89; p<0.01) compared to nimodipine alone. Three trials reported adverse events. Methodological quality of the included studies was judged to be generally poor. Conclusions Acupuncture appears effective for AMCI when used as an alternative or adjunctive treatment; however, caution must be exercised given the low methodological quality of included trials. Further, more rigorously designed studies are needed.

scholarly journals Efficacy and safety of omalizumab in chronic rhinosinusitis with nasal polyps: a systematic review and meta-analysis of randomised controlled trials

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e047344
Author(s):  
Qingwu Wu ◽  
Lianxiong Yuan ◽  
Huijun Qiu ◽  
Xinyue Wang ◽  
Xuekun Huang ◽  
...  
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Chronic Rhinosinusitis ◽  
Randomised Controlled Trials ◽  
Nasal Polyps ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomised Controlled

ObjectivesTo assess the efficacy and safety of omalizumab for chronic rhinosinusitis with nasal polyps (CRSwNP) and to identify evidence gaps that will guide future research on omalizumab for CRSwNP.DesignSystematic review and meta-analysis.Data sourcesA comprehensive search was performed in PubMed, Embase, Web of Science and the Cochrane Library on 13 October 2020.Eligibility criteriaRandomised controlled trials (RCTs) comparing omalizumab with placebo, given for at least 16 weeks in adult patients with CRSwNP.Data extraction and synthesisTwo independent authors screened search results, extracted data and assessed studies using the Cochrane risk of bias tool. Data were pooled using the inverse-variance method and expressed as mean differences (MDs) with 95% CIs. Heterogeneity was assessed by the χ2 test and the I2 statistic.ResultsA total of four RCTs involving 303 participants were identified. When comparing omalizumab to placebo, there was a significant difference in Nasal Polyps Score (MD=−1.20; 95% CI −1.48 to −0.92), Nasal Congestion Score (MD=−0.67; 95% CI −0.86 to −0.48), Sino-Nasal Outcome Test-22 (MD=−15.62; 95% CI −19.79 to −11.45), Total Nasal Symptom Score (MD=−1.84; 95% CI −2.43 to −1.25) and reduced need for surgery (risk ratio (RR)=5.61; 95% CI 1.99 to 15.81). Furthermore, there was no difference in the risk of serious adverse events ((RR=1.40; 95% CI 0.29 to 6.80), adverse events (RR=0.83; 95% CI 0.60 to 1.15) and rescue systemic corticosteroid (RR=0.52; 95% CI 0.17 to 1.61).ConclusionsThis was the first meta-analysis that identified omalizumab significantly improved endoscopic, clinical and patient-reported outcomes in adults with moderate to severe CRSwNP and it was safe and well tolerated.PROSPERO registration numberCRD42020207639.

scholarly journals Impact of PCSK9 monoclonal antibodies on circulating hs-CRP levels: a systematic review and meta-analysis of randomised controlled trials

BMJ Open ◽  
2018 ◽  
Vol 8 (9) ◽  
pp. e022348 ◽  
Author(s):  
Ye-Xuan Cao ◽  
Sha Li ◽  
Hui-Hui Liu ◽  
Jian-Jun Li
Keyword(s):  
Systematic Review ◽  
Treatment Duration ◽  
Randomised Controlled Trials ◽  
Familial Hypercholesterolaemia ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Participant Characteristics ◽  
Hs Crp ◽  
Randomised Controlled

ObjectiveTo evaluate the potential effects of proprotein convertase subtilisin/kexin type 9 monoclonal antibody (PCSK9-mAb) on high-sensitivity C reactive protein (hs-CRP) concentrations.DesignA systematic review and meta-analysis of randomised controlled trials.Data sourcesPubMed, MEDLINE, the Cochrane Library databases, ClinicalTrials.gov and recent conferences were searched from inception to May 2018.Eligibility criteria for selecting studiesAll randomised controlled trials that reported changes of hs-CRP were included.ResultsTen studies involving 4198 participants were identified. PCSK9-mAbs showed a slight efficacy in reducing hs-CRP (−0.04 mg/L, 95% CI: −0.17 to 0.01) which was not statistically different. The results did not altered when subgroup analyses were performed including PCSK9-mAb types (alirocumab: 0.12 mg/L, 95% CI: −0.18 to 0.43; evolocumab: 0.00 mg/L, 95% CI: −0.07 to 0.07; LY3015014: −0.48 mg/L, 95% CI: −1.28 to 0.32; RG7652: 0.35 mg/L, 95% CI: −0.26 to 0.96), treatment duration (≤12w: 0.00 mg/L, 95% CI: −0.07 to 0.07; >12w: −0.11 mg/L, 95% CI: −0.45 to −0.23), participant characteristics (familial hypercholesterolaemia: 0.00 mg/L, 95% CI: −0.07 to 0.07; non-familial hypercholesterolaemia: 0.07 mg/L, 95% CI: −0.12 to 0.26; mix: −0.48 mg/L, 95% CI: −1.28 to 0.32) and treatment methods (monotherapy: 0.00 mg/L, −0.08 to 0.07; combination therapy: −0.08 mg/L, −0.37 to 0.21). Meta-regression analyses suggested no significant linear correlation between baseline age (p=0.673), sex (p=0.645) and low-density lipoprotein cholesterol reduction (p=0.339).ConclusionsOur updated meta-analysis suggested that PCSK9-mAbs had no significant impact on circulating hs-CRP levels irrespective of PCSK9-mAb types, participant characteristics and treatment duration or methods.

Adjunct treatment in snakebite envenoming: a systematic review of randomised controlled trials

2020 ◽  
Vol 114 (11) ◽  
pp. 847-857
Author(s):  
Chaturaka Rodrigo ◽  
Ariaranee Gnanathasan
Keyword(s):  
Systematic Review ◽  
Randomised Controlled Trials ◽  
Fresh Frozen Plasma ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Adjunct Therapy ◽  
Adjunct Treatment ◽  
Fresh Frozen ◽  
Randomised Controlled ◽  
Frozen Plasma

Abstract Adjunct therapy in snakebite may be lifesaving if administered appropriately or can be harmful if non-judicious use leads to avoidable delays in administering antivenom. This systematic review analyses the evidence from randomised controlled trials (RCTs) on the efficacy of adjunct treatment administered with antivenom. PubMed, EMBASE, Scopus, Cochrane library and CINAHL were searched for RCTs enrolling patients with snakebite envenoming where a treatment other than antivenom has been assessed for its efficacy within the last 25 y. Fifteen studies met the inclusion criteria. The interventions assessed were categorised as adjunct therapies (heparin or fresh frozen plasma) to reverse haemotoxicity (three studies), antibiotics to prevent local infections (three studies), steroids to reduce local swelling (one study), premedication (adrenaline, steroids and antihistamines, either alone or in combination) to reduce hypersensitivity reactions to antivenom (five studies) and other interventions (three studies). Apart from a beneficial effect of low-dose adrenaline (1:1000, 0.25 ml administered subcutaneously) in preventing antivenom-induced hypersensitivities (OR: 0.54, 95% CI 0.32 to 0.93, two RCTs, 354 participants, moderate certainty evidence) in Sri Lanka, evidence for any other adjunct therapy is either non-existent or needs confirmation by larger better designed trials.

Therapeutic effect of resveratrol supplementation on oxidative stress: a systematic review and meta-analysis of randomised controlled trials

2019 ◽  
Vol 96 (1134) ◽  
pp. 197-205 ◽  
Author(s):  
Mehdi Koushki ◽  
Mostafa Lakzaei ◽  
Hadi Khodabandehloo ◽  
Hossein Hosseini ◽  
Reza Meshkani ◽  
...  
Keyword(s):  
Oxidative Stress ◽  
Systematic Review ◽  
Publication Bias ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Oxidative Markers ◽  
Markers Of Oxidative Stress ◽  
Randomised Controlled

BackgroundResveratrol is a naturally occurring polyphenol compound mainly found in grapes and red wine. The evidence has suggested that resveratrol has an antioxidant effect. However, the results are inconsistent and inconclusive. Thus, we conducted a systematic review and meta-analysis to evaluate the effect of resveratrol supplementation on markers of oxidative stress.MethodsWe searched PubMed, ISI Web of Science, EMBASE, Scopus and the Cochrane library up to December 2018 to identify randomised controlled trials (RCTs) assessing resveratrol supplementation effects on oxidative markers. Heterogeneity, publication bias, risk of bias and subgroup analysis were analysed. This meta-analysis was conducted in accordance with the guidelines of the Preferred ReportingItems for Systematic Reviews and Meta-Analysis (PRISMA).ResultsMeta-analysis of data from 12 RCTs did not support significant effect of resveratrol supplementation on circulating levels of superoxide dismutase (SOD) (standardized mean difference (SMD) (1.12), (95% CI −0.91 to 3.1), p=0.28), catalase (CAT) (SMD (−0.07), (95% CI −1.4 to 1.3), p=0.92) and glutathione peroxidase (GPx) (SMD (−0.76), (95% CI −2.56 to 1.04), p=0.40). Although, resveratrol supplementation increased significantly circulating total antioxidant capacity (TAC) concentrations (SMD (0.52), (95% CI −0.02 to 1.07), p=0.05). Severe heterogeneity was observed between studies, and no obvious publication bias was observed in included RCTs.ConclusionCollectively, our findings of available RCTs did no show any benefit of resveratrol supplementation on SOD, CAT and GPx except for TAC. Well-designed RCTs are necessary to confirm these results.

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