Are orthodontic randomised controlled trials justified with a citation of an appropriate systematic review?

Abstract Background A systematic review of the evidence should be undertaken to support the justification for undertaking a clinical trial. The aim of this study was to examine whether reports of orthodontic Randomised Clinical Trials (RCTs) cite prior systematic reviews (SR) to explain the rationale or justification of the trial. Study characteristics that predicated the citation of SR in the RCT report were also explored. Material and methods Orthodontic RCTs published between 1st January 2010 to 31st December 2020 in seven orthodontic journals were identified. All titles and abstracts were screened independently by two authors. Descriptive statistics and associations were assessed for the study characteristics. Logistic regression was used to identify predicators of SR inclusion in the trial report. Results 301 RCTs fulfilling the eligibility criteria were assessed. 220 SRs were available of which 74.5% (N = 164) were cited, and 24.5% (N = 56) were not included but were available in the literature within 12 months of trial commencement. When a SR was not included in the introduction or no SR was available within 12 months of trial commencement, interventional studies were commonly cited. The continent of the corresponding author predicated the possibility of inclusion of a SR in the introduction (OR 0.36; 95% CI 0.18–0.71; p = 0.003). Conclusions A quarter of orthodontic RCTs (24.5%) included in this study did not cite a SR in the introduction section to justify the rationale of the trial when a relevant SR was available. To reduce research waste and optimal usage of resources, researchers should identify or conduct a systematic review of the evidence to support the rationale and justification of the trial.

Download Full-text

The influence of study characteristics on reporting of subgroup analyses in randomised controlled trials: systematic review

BMJ ◽

10.1136/bmj.d1569 ◽

2011 ◽

Vol 342 (mar28 1) ◽

pp. d1569-d1569 ◽

Cited By ~ 53

Author(s):

X. Sun ◽

M. Briel ◽

J. W. Busse ◽

J. J. You ◽

E. A. Akl ◽

...

Keyword(s):

Systematic Review ◽

Randomised Controlled Trials ◽

Controlled Trials ◽

Subgroup Analyses ◽

Study Characteristics ◽

Randomised Controlled

Download Full-text

Interventions for oropharyngeal dysphagia in acute and critical care: a protocol for a systematic review and meta-analysis

Systematic Reviews ◽

10.1186/s13643-019-1196-0 ◽

2019 ◽

Vol 8 (1) ◽

Cited By ~ 4

Author(s):

Sallyanne Duncan ◽

Jennifer Mc Gaughey ◽

Richard Fallis ◽

Daniel F. McAuley ◽

Margaret Walshe ◽

...

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Critical Care ◽

Acute Care ◽

Randomised Controlled Trials ◽

Meta Analysis ◽

Oropharyngeal Dysphagia ◽

Length Of Hospital Stay ◽

Controlled Trials ◽

Randomised Controlled

Abstract Background Oropharyngeal dysphagia or swallowing difficulties are common in acute care and critical care, affecting 47% of hospitalised frail elderly, 50% of acute stroke patients and approximately 62% of critically ill patients who have been intubated and mechanically ventilated for prolonged periods. Complications of dysphagia include aspiration leading to chest infection and pneumonia, malnutrition, increased length of hospital stay and re-admission to hospital. To date, most dysphagia interventions in acute care have been tested with acute stroke populations. While intervention studies in critical care have been emerging since 2015, they are limited and so there is much to learn about the type, the delivery and the intensity of treatments in this setting to inform future clinical trials. The aim of this systematic review is to summarise the evidence regarding the relationship between dysphagia interventions and clinically important patient outcomes in acute and critical care settings. Methods We will search MEDLINE, EMBASE, CENTRAL, Web of Science, CINAHL and clinical trial registries from inception to the present. We will include studies conducted with adults in acute care settings such as acute hospital wards or units or intensive care units and critical care settings. Studies will be restricted to randomised controlled trials and quasi-randomised controlled trials comparing a new dysphagia intervention with usual care or another intervention. The main outcomes that will be collected include length of time taken to return to oral intake, change in incidence of aspiration and pneumonia, nutritional status, length of hospital stay and quality of life. Key intervention components such as delivery, intensity, acceptability, fidelity and adverse events associated with such interventions will be collected to inform future clinical trials. Two independent reviewers will assess articles for eligibility, data extraction and quality appraisal. A meta-analysis will be conducted as appropriate. Discussion No systematic review has attempted to summarise the evidence for oropharyngeal dysphagia interventions in acute and critical care. Results of the proposed systematic review will inform practice and the design of future clinical trials. Systematic review registration PROSPERO CRD 42018116849 (http://www.crd.york.ac.uk/PROSPERO/)

Download Full-text

Clinical outcomes and outcome measurement tools reported in randomised controlled trials of treatment for snakebite envenoming: A systematic review

PLoS Neglected Tropical Diseases ◽

10.1371/journal.pntd.0009589 ◽

2021 ◽

Vol 15 (8) ◽

pp. e0009589

Author(s):

Michael Abouyannis ◽

Dinesh Aggarwal ◽

David G. Lalloo ◽

Nicholas R. Casewell ◽

Mainga Hamaluba ◽

...

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Outcome Measures ◽

Randomised Controlled Trials ◽

Core Outcome Set ◽

Controlled Trials ◽

Study Protocols ◽

Outcome Set ◽

Secondary Analyses ◽

Randomised Controlled

Background Snakebite is a priority neglected tropical disease and causes a range of complications that vary depending on the snake species. Randomised clinical trials have used varied outcome measures that do not allow results to be compared or combined. In accordance with the Core Outcomes Measurements in Effectiveness Trials (COMET) initiative, this systematic review aims to support the development of a globally relevant core outcome set for snakebite. Methods All randomised controlled trials, secondary analyses of randomised controlled trials and study protocols investigating the efficacy of therapeutics for human snakebite envenoming were eligible for inclusion. Study screening and data extraction were conducted in duplicate by two independent reviewers. All primary and secondary outcome measures were extracted and compiled, as were adverse event outcome measures. Similar outcome measures were grouped into domains. The study was prospectively registered with PROSPERO: CRD42020196160. Results This systematic review included 43 randomised controlled trials, two secondary analyses and 13 study protocols. A total of 382 outcome measures were extracted and, after duplicates were merged, there were 153 unique outcomes. The most frequently used outcome domain (‘venom antigenaemia’) was included in less than one third of the studies. The unique outcomes were classified into 60 outcome domains. Patient-centred outcomes were used in only three of the studies. Discussion Significant heterogeneity in outcome measures exists in snakebite clinical trials. Consensus is needed to select outcome measures that are valid, reliable, patient-centred and feasible. The results of this systematic review strongly support the development of a core outcome set for use in snakebite clinical trials.

Download Full-text

Workplace programmes for supporting breast-feeding: a systematic review and meta-analysis

Public Health Nutrition ◽

10.1017/s1368980020004012 ◽

2020 ◽

pp. 1-13

Author(s):

Xueying Tang ◽

Peta Patterson ◽

Kristen MacKenzie-Shalders ◽

Louise A van Herwerden ◽

Jo Bishop ◽

...

Keyword(s):

Systematic Review ◽

Breast Feeding ◽

Randomised Controlled Trials ◽

Meta Analysis ◽

Controlled Trials ◽

Eligibility Criteria ◽

Positive Direction ◽

The Usa ◽

Expectant Fathers ◽

Randomised Controlled

Abstract Objective: To critically review the literature regarding workplace breast-feeding interventions and to assess their impact on breast-feeding indicators. Design: A systematic review and meta-analysis was conducted. Electronic searches for workplace intervention studies to support breast-feeding, without restriction on language or study design, were performed in PubMed, CENTRAL, CINAHL, Embase, Web of Science, Business Source Complete, ProQuest-Sociology and ProQuest-Social Science to 13 April 2020. A meta-analysis of the pooled effect of the programmes on breast-feeding indicators was conducted. Results: The search identified 10 215 articles; fourteen studies across eighteen publications met eligibility criteria. Programmes were delivered in the USA (n 10), Turkey (n 2), Thailand (n 1) or Taiwan (n 1). There were no randomised controlled trials. The pooled OR for exclusive breast-feeding at 3 or 6 months for participants v. non-participants of three non-randomised controlled studies was 3·21 (95 % CI 1·70, 6·06, I2 = 22 %). Despite high heterogeneity, other pooled outcomes were consistently in a positive direction with acceptable CI. Pooled mean duration of breast-feeding for five single-arm studies was 9·16 months (95 % CI 8·25, 10·07). Pooled proportion of breast-feeding at 6 months for six single-arm studies was 0·76 (95 % CI 0·66, 0·84) and breast-feeding at 12 months for three single-arm studies was 0·41 (95 % CI 0·22, 0·62). Most programmes were targeted at mothers; two were targeted at expectant fathers. Conclusions: Workplace programmes may be effective in promoting breast-feeding among employed mothers and partners of employed fathers. However, no randomised controlled trials were identified, and better-quality research on workplace interventions to improve breast-feeding is needed.

Download Full-text

Intravenous rehydration of malnourished children with acute gastroenteritis and severe dehydration: A systematic review

Wellcome Open Research ◽

10.12688/wellcomeopenres.12346.1 ◽

2017 ◽

Vol 2 ◽

pp. 65 ◽

Cited By ~ 3

Author(s):

Kirsty A. Houston ◽

Jack G. Gibb ◽

Kathryn Maitland

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Acute Gastroenteritis ◽

Randomised Controlled Trials ◽

Fluid Overload ◽

Current Therapy ◽

Controlled Trials ◽

Severe Dehydration ◽

Intravenous Rehydration ◽

Randomised Controlled

Background: Rehydration strategies in children with severe acute malnutrition (SAM) and severe dehydration are extremely cautious. The World Health Organization (WHO) SAM guidelines advise strongly against intravenous fluids unless the child is shocked or severely dehydrated and unable to tolerate oral fluids. Otherwise, guidelines recommend oral or nasogastric rehydration using low sodium oral rehydration solutions. There is limited evidence to support these recommendations. Methods: We conducted a systematic review of randomised controlled trials (RCTs) and observational studies on 15th June 2017 comparing different strategies of rehydration therapy in children with acute gastroenteritis and severe dehydration, specifically relating to intravenous rehydration, using standard search terms. Two authors assessed papers for inclusion. The primary endpoint was evidence of fluid overload. Results: Four studies were identified, all published in English, including 883 children, all of which were conducted in low resource settings. Two were randomised controlled trials and two observational cohort studies, one incorporated assessment of myocardial and haemodynamic function. There was no evidence of fluid overload or other fluid-related adverse events, including children managed on more liberal rehydration protocols. Mortality was high overall, and particularly in children with shock managed on WHO recommendations (day-28 mortality 82%). There was no difference in safety outcomes when different rates of intravenous rehydration were compared. Conclusions: The current ‘strong recommendations’ for conservative rehydration of children with SAM are not based on emerging evidence. We found no clinical trials providing a direct assessment of the current WHO guidelines, and those that were available suggested that these children have a high mortality and remain fluid depleted on current therapy. Recent studies have reported no evidence of fluid overload or heart failure with more liberal rehydration regimens. Clinical trials are urgently required to inform guidelines on routes and rates of intravenous rehydration therapy for dehydration in children with SAM.

Download Full-text

Effectiveness of online interventions in preventing depression: a protocol for systematic review and meta-analysis of randomised controlled trials

BMJ Open ◽

10.1136/bmjopen-2018-022012 ◽

2018 ◽

Vol 8 (11) ◽

pp. e022012 ◽

Cited By ~ 1

Author(s):

Alina Rigabert ◽

Emma Motrico ◽

Patricia Moreno-Peral ◽

Davinia M Resurrección ◽

Sonia Conejo-Cerón ◽

...

Keyword(s):

Systematic Review ◽

Randomised Controlled Trials ◽

Meta Analysis ◽

Random Effect ◽

Psychosocial Interventions ◽

Controlled Trials ◽

Cochrane Central Register ◽

Online Interventions ◽

Eligibility Criteria ◽

Randomised Controlled

IntroductionAlthough evidence exists for the efficacy of psychosocial interventions in preventing depression, little is known about its prevention through online interventions. The objective of this study is to conduct a systematic review and meta-analysis of randomised controlled trials assessing the effectiveness of online interventions in preventing depression in heterogeneous populations.Methods and analysisWe will conduct a systematic review and meta-analysis of randomised controlled trials that will be identified through searches of PubMed, PsycINFO, WOS, Scopus, OpenGrey, Cochrane Central Register of Controlled Trials, ClinicalTrials.gov and Australia New Zealand Clinical Trials Register . We will also search the reference lists provided in relevant studies and reviews. Experts in the field will be contacted to obtain more references. Two independent reviewers will assess the eligibility criteria of all articles, extract data and determine their risk of bias (Cochrane Collaboration Tool). Baseline depression will be required to have been discarded through standardised interviews or validated self-reports with standard cut-off points. The outcomes will be the incidence of new cases of depression and/or the reduction of depressive symptoms as measured by validated instruments. Pooled standardised mean differences will be calculated using random-effect models. Heterogeneity and publication bias will be estimated. Predefined sensitivity and subgroup analyses will be performed. If heterogeneity is relevant, random-effect meta-regression will be performed.Ethics and disseminationThe results will be disseminated through peer-reviewed publication and will be presented at a professional conference. Ethical assessment is not required as we will search and assess existing sources of literature.Trial registration numberCRD42014014804; Results.

Download Full-text

Is patellofemoral pain preventable? A systematic review and meta-analysis of randomised controlled trials

British Journal of Sports Medicine ◽

10.1136/bjsports-2020-102973 ◽

2020 ◽

pp. bjsports-2020-102973

Author(s):

Adam G Culvenor ◽

Marienke van Middelkoop ◽

Erin M Macri ◽

Kay M Crossley

Keyword(s):

Systematic Review ◽

Randomised Controlled Trials ◽

Meta Analysis ◽

Patellofemoral Pain ◽

Controlled Trials ◽

Eligibility Criteria ◽

Military Recruits ◽

Exercise Dose ◽

Exercise Programmes ◽

Randomised Controlled

ObjectiveTo evaluate the effectiveness of interventions to reduce the risk of incident patellofemoral pain.DesignSystematic review and meta-analysis, with strength of evidence evaluated separately for each intervention type.Data sourcesMEDLINE, EMBASE, CINAHL, Web of Science and SPORTDiscus.Eligibility criteria for selecting studiesRandomised controlled trials evaluating the effectiveness of interventions to reduce patellofemoral pain risk compared with a control/non-exposed group.ResultsThirteen trials of mostly military recruits and young athletes analysed six different interventions. There was low certainty evidence from two trials (227 participants) that patellofemoral braces worn during physical activity (compared with no brace) effectively reduced the risk of patellofemoral pain (risk ratio (RR) 0.40, 95% CI 0.22 to 0.73; I2=24.0%). There was low certainty evidence from one trial (320 participants) that running technique retraining to (run softer) reduced patellofemoral pain risk (RR 0.21, 95% CI 0.07 to 0.60). There was low certainty evidence from four trials (3364 participants) that multicomponent (strengthening/neuromuscular) exercise programmes did not significantly reduce the risk of patellofemoral pain (RR 0.49, 95% CI 0.18 to 1.36; I2=64.9%), although broad CIs may reflect exercise dose variations among studies. There was very low certainty evidence from four trials (2314 participants) that foot orthoses (compared with flat inserts/no orthosis) did not significantly reduce the risk of patellofemoral pain (RR 0.63, 95% CI 0.35 to 1.13; I2=0.0%). Static stretching and a running programme that progressed intensity (compared with volume) did not significantly influence patellofemoral pain risk (single studies).ConclusionThere is low-level evidence that patellofemoral braces and running technique retraining can reduce the risk of patellofemoral pain by 60%–79%.

Download Full-text

Systematic Review and Meta-Analysis of the Use of Hyaluronic Acid Injections to Restore Interproximal Papillae

Applied Sciences ◽

10.3390/app112210572 ◽

2021 ◽

Vol 11 (22) ◽

pp. 10572

Author(s):

Arturo Sanchez-Perez ◽

Tania Rosa Vela-García ◽

Bibiana Mateos-Moreno ◽

Alfonso Jornet-García ◽

Carlos Navarro-Cuellar

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Hyaluronic Acid ◽

Social Relationships ◽

Treatment Strategy ◽

Randomised Controlled Trials ◽

Meta Analysis ◽

Controlled Trials ◽

Interdental Papilla ◽

Randomised Controlled

The absence of interdental papillae leads to the appearance of black triangles. For most patients, the appearance of these triangles is an important reason for concern and affects their social relationships. Multiple reconstruction techniques have been developed with different degrees of success and predictability. The main aim of this study was to evaluate the efficiency of hyaluronic acid (HA) injected into interproximal papillae 6 months after injection and to perform a systematic review and meta-analysis. After a systematic review, seven articles were selected: two clinical randomised controlled trials and five clinical trials. In total, 127 patients with a deficiency in upper papillae in the front of the maxilla and jaw were included in the study. The height variable was evaluated (mm) 6 months after HA injection. In total, 166 interproximal papillae were studied. Four articles showed an important difference in favour of intervention. The total result regarding in the injection of HA was favourable with an approximate average filling of 0.47 mm in the height of the interdental papilla. The injection of HA for the reconstruction of deficient papillae in the region of the upper and lower maxilla was a possible option treatment strategy in mild black triangles.

Download Full-text

Biologic discontinuation studies: a systematic review of methods

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2013-203302 ◽

2013 ◽

Vol 73 (3) ◽

pp. 595-599 ◽

Cited By ~ 33

Author(s):

Kazuki Yoshida ◽

Yoon-Kyoung Sung ◽

Arthur Kavanaugh ◽

Sang-Cheol Bae ◽

Michael E Weinblatt ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Systematic Review ◽

Clinical Trials ◽

Randomised Controlled Trials ◽

Controlled Trials ◽

Biologic Drugs ◽

Scientific Meetings ◽

Randomised Controlled ◽

Time Point

ObjectivesWe conducted a systematic review to assess the design and ‘failure definition’ in studies of biologic discontinuation in rheumatoid arthritis (RA).MethodsWe found 403 studies on PubMed, and included nine published papers and five abstracts from scientific meetings. We used a structured extraction form to collect information regarding study design and outcome (failure) definition.ResultsThree types of studies were found: randomised controlled trials, long-term extension studies of clinical trials and prospective discontinuation studies. The largest study had 196 subjects in the discontinuation arm. Most studies allowed concomitant use of non-biologic drugs at biologic discontinuation. Heterogeneity was also found in the failure definition. Although all studies used measures of disease activity, the threshold for failure and the time point of assessment differed among studies. Few studies incorporated changing use of non-biologic drugs or glucocorticoids into the failure definition.ConclusionsAlthough many studies have examined the outcome of biologic discontinuation, they have all been relatively small. Typical practice studies from registries may add important information but will likely need to rely on a broader failure definition.

Download Full-text

Minocycline for the treatment of mental health and neurological conditions: study protocol of a systematic review and meta-analysis

BMJ Open ◽

10.1136/bmjopen-2019-035080 ◽

2020 ◽

Vol 10 (3) ◽

pp. e035080

Author(s):

Chiara C Bortolasci ◽

Wolfgang Marx ◽

Adam J Walker ◽

Kyoko Hasebe ◽

Bianca E Kavanagh ◽

...

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Neurological Disorders ◽

Randomised Controlled Trials ◽

Meta Analysis ◽

Risk Of Bias ◽

Sufficient Evidence ◽

Controlled Trials ◽

Controlled Clinical Trials ◽

Randomised Controlled

IntroductionDue to the anti-inflammatory, antioxidant and anti-apoptotic properties of minocycline, clinical trials have evaluated the potential of this drug to treat several psychiatric and neurological disorders, including major depressive disorder, schizophrenia, bipolar disorder, stroke and amyotrophic lateral sclerosis. This protocol proposes a systematic review (and potential meta-analysis) that aims to identify and critically evaluate randomised controlled trials of minocycline for treating psychiatric and neurological disorders.Methods and analysisPubMed, Embase, Cochrane Central Register of Controlled Clinical Trials, PsycINFO and Cumulative Index to Nursing and Allied Health Literature (CINAHL) will be used to identify randomised controlled trials that used minocycline to treat psychiatric and neurological disorders. Double-blind, randomised, controlled, clinical trials of participants aged 18 years or older and written in English will be included in the review. Data will be extracted by two independent reviewers. Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines will be followed and the Cochrane Collaboration’s ‘Risk of Bias’ tool will be used to assess the risk of bias in all studies included in the systematic review. The Grading of Recommendations, Assessment, Development and Evaluation system will be used to access the overall quality of the level of evidence of the studies. If sufficient evidence is identified, a meta-analysis will be conducted using the standardised mean difference approach and reported with 95% CIs. Heterogeneity of evidence will be evaluated using the I2model.Ethics and disseminationThis systematic review will evaluate only published data; therefore, ethical approval is not required. The systematic review will be published in a peer-reviewed journal and presented at relevant research conferences.Trial registration numberCRD42020153292.

Download Full-text