The Reporting Quality of Randomized Controlled Trials in Orthodontics

ObjectivesAccurate trial reporting facilitates evaluation and better use of study results. The objective of this article is to investigate the quality of reporting of randomized controlled trials (RCTs) in leading orthodontic journals, and to explore potential predictors of improved reporting.MethodsThe 50 most recent issues of 4 leading orthodontic journals until November 2013 were electronically searched. Reporting quality assessment was conducted using the modified CONSORT statement checklist. The relationship between potential predictors and the modified CONSORT score was assessed using linear regression modeling.Results128 RCTs were identified with a mean modified CONSORT score of 68.97% (SD = 11.09). The Journal of Orthodontics (JO) ranked first in terms of completeness of reporting (modified CONSORT score 76.21%, SD = 10.1), followed by American Journal of Orthodontics and Dentofacial Orthopedics (AJODO) (73.05%, SD = 10.1). Journal of publication (AJODO: β = 10.08, 95% CI: 5.78, 14.38; JO: β = 16.82, 95% CI: 11.70, 21.94; EJO: β = 7.21, 95% CI: 2.69, 11.72 compared to Angle), year of publication (β = 0.98, 95% CI: 0.28, 1.67 for each additional year), region of authorship (Europe: β = 5.19, 95% CI: 1.30, 9.09 compared to Asia/other), statistical significance (significant: β = 3.10, 95% CI: 0.11, 6.10 compared to non-significant) and methodologist involvement (involvement: β = 5.60, 95% CI: 1.66, 9.54 compared to non-involvement) were all significant predictors of improved modified CONSORT scores in the multivariable model. Additionally, median overall Jadad score was 2 (IQR = 2) across journals, with JO (median = 3, IQR = 1) and AJODO (median = 3, IQR = 2) presenting the highest score values.ConclusionThe reporting quality of RCTs published in leading orthodontic journals is considered suboptimal in various CONSORT areas. This may have a bearing in trial result interpretation and use in clinical decision making and evidence- based orthodontic treatment interventions.     

Comparison of adverse events between cluster and conventional immunotherapy for allergic rhinitis patients with or without asthma: A systematic review and meta-analysis

BackgroundCluster schedule of allergen-specific immunotherapy (AIT) is a cost-effective choice for allergic rhinitis (AR) patients, but its safety has been questioned due to the greater dosages required at each treatment compared with conventional immunotherapy. It remains a question that whether cluster schedule leads to a higher risk of side effects.ObjectiveThis study was designed to update the evidence and investigate whether cluster schedule leads to a higher risk of local adverse reactions (LARs) and systemic adverse reactions (SARs) than cluster schedule does.MethodsWe searched the Cochrane Central Register of Controlled Trials, EMBASE and Medline thoroughly and included studies comparing cluster and conventional schedules. A meta-analysis of 5 outcomes related to adverse events was performed after bias and heterogeneity assessments. And as a result of language limitations, we considered only articles in Chinese and English.Results5 observational studies and 6 interventional studies were included in the meta-analysis. There were no differences between cluster and conventional schedules when analyzing SARs by the number of patients, delayed SARs, grade 2 SARs and LARs. Analyses of SARs by injection, grade 1 SARs and LARs by injection in observational studies showed that cluster schedule had a lower risk of adverse events than did conventional schedule.ConclusionOur data suggest that cluster schedule is as safe as or even safer than conventional schedule for AR patients with or without asthma (AS).     

Assessing generalisability by location in trial-based cost-effectiveness analysis: the use of multilevel models

Cost-effectiveness analysis (CEA) in health care is increasingly conducted alongside multicentre and multinational randomised controlled clinical trials (RCTs). The increased use of stochastic CEA is designed to account for between-patient sampling variability in cost-effectiveness data assuming that observations are independently distributed. However, between-location variability in cost-effectiveness may result if there is a hierarchical structure in the data; that is, if there is correlation in costs and outcomes between patients recruited in particular locations. This may be expected in multi-location trials given that centres and countries often differ in factors such as clinical practice, patient case-mix and the unit costs of delivering health care. A failure to acknowledge this feature may lead to misleading conclusions in a trial-based economic study. Multilevel modelling (MLM) is an analytical framework that can be used to handle hierarchical cost-effectiveness data. Using data from a recently conducted economic analysis, this paper shows how multilevel modelling can be used to obtain (a) more appropriate estimates of the population average incremental cost-effectiveness and associated standard errors compared to standard stochastic CEA; and (b) location-specific estimates of incremental cost-effectiveness which can be used to explore appropriately the variability between centres/countries of the cost-effectiveness results.     

Meta-analysis of recombinant versus urinary-derived FSH: an update

BACKGROUND: The study aim was to analyse the results of randomized controlled trials (RCTs) comparing recombinant FSH and urinary-derived FSH gonadotrophins [hMG, urinary purified FSH (FSH-P) and highly purified FSH (FSH-HP)] in an IVF/ICSI programme. METHODS: All published truly RCTs using a long protocol of GnRH agonists for down-regulation, were reviewed. Data of pregnancy rate per started cycle were extracted, and odds ratios (OR) calculated using a fixed effect model. Subgroup analysis was carried out to compare recombinant FSH (rFSH) with each product (hMG alone, FSH-P alone and FSH-HP alone). RESULTS: There was no statistically significant difference in the pregnancy rate per started cycle between rFSH and urinary-derived FSH gonadotrophins (OR 1.07; 95% CI 0.94-1.22). Subgroup analysis showed no statistically significant difference in the pregnancy rate per started cycle between rFSH versus hMG (OR 0.81; 95% CI 0.63-1.05), rFSH versus FSH-P (OR 1.24; 95% CI 0.98-1.58) and rFSH versus FSH-HP (OR 1.14; 95% CI 0.94-1.40). There was no significant heterogeneity of treatment effect across the trials. CONCLUSIONS: There is no evidence of clinical superiority in clinical pregnancy rate for rFSH over different urinary-derived FSH gonadotrophins. Additional factors should be considered when choosing a gonadotrophin regimen, including the cost, patient acceptability, safety and drug availability.     

Barriers and facilitators to participant recruitment to randomised controlled trials: A qualitative perspective

Low recruitment rates for randomised controlled trials (RCTs) are a common issue. Information on barriers and facilitators to recruitment for RCTs may inform researchers on how to improve the recruitment rate. The aim of this qualitative project was to identify barriers and facilitators to participant recruitment for a randomised double‐blinded placebo‐controlled trial on the clinical effectiveness of aspirin as an adjunct to compression therapy in healing chronic venous leg ulcers. We have conducted interviews with health professionals and project workers to understand their perspective on low recruitment rate, barriers to, and facilitators of recruitment. NVivo 11 software was used for data management and coding. Thematic analysis was applied as a method of data analysis. Although strict recruitment criteria were the main barrier, there were other recruitment barriers that should be considered when planning RCTs. We have further developed a framework of factors influencing the recruitment rate. The main recruitment barriers, including study‐related, participant‐related, practitioner‐related, collaboration‐related, ethics‐related, practice‐related, and health system‐related barriers, should be considered for inclusion in the “Other Information” section of Consolidated Standards of Reporting Trials Statement to improve the quality of reporting and ensure the strategic planning of future RCTs.     

Enhancing the validity and utility of randomized clinical trials in addictions treatment research: III. Data processing and statistical analysis

PURPOSE: This is the third paper in a series that reviews strategies for optimizing the validity and utility of randomized clinical trials (RCTs) in addictions treatment research. Whereas the two previous papers focused on design and implementation, here we address issues pertaining to data processing and statistical analysis. SCOPE: Recommendations for enhancing data quality and utility are offered in sections on data coding and entry; and data format, structure and management. We discuss the need for preliminary data analyses that examine statistical power; patterns of attrition; between-group equivalence; and treatment integrity and discriminability. We discuss tests of treatment efficacy, as well as ancillary analyses aimed at explicating treatment processes. CONCLUSIONS: Safeguards are necessary to protect data quality, and advance planning is needed to ensure that data formats are compatible with statistical objectives. In addition to treatment efficacy, statistical analyses should evaluate study internal and external validity, and investigate the change mechanisms that underlie treatment effects.     

An updated meta-analysis to assess the effectiveness of psychological interventions delivered by psychological specialists and generalist clinicians on glycaemic control and on psychological status

Objective

To update a meta-analysis and determine the effectiveness of psychological interventions on glycaemic control measured by HbA_1c and psychological status in type 2 diabetes and to compare effects when interventions are delivered by generalist clinicians compared to psychological specialists.

Methods

We used the original review protocol and searched the Cochrane central register of controlled trials, Medline, Embase, PsychLIT, and Google Scholar from February 2003 (end of previous review) to March 2007. We extracted data on the participants, interventions, delivery methods, comparison groups and outcome measures.

Results

35 trials were reviewed and meta-analysis of 19 trials (n = 1431), reporting HbA_1c found a reduction in HbA_1c by 0.54% (−0.32; 95% CI: −0.47 to −0.16). In nine trials (n = 832) interventions were delivered by diabetes or general clinicians reducing HbA_1c by 0.51% (−0.27; 95% CI: −0.50 to 0.04). In nine trials, interventions (n = 561) were delivered by psychological specialists reducing HbA_1c by 0.57% (−0.36; 95% CI: −0.61 to 0.12). Meta-analysis of 13 trials reporting psychological status found psychological status to be lower in the intervention groups −0.56 (95% CI: 1.00 to −0.13). Trial quality for the majority of studies remained poor.

Conclusion

Our findings suggest that psychological and general clinicians are similarly effective in delivering psychological interventions, however, effect sizes for all clinicians have reduced since the earlier review.

Practice implications

Psychological training opportunities for generalist clinicians could lead to wider availability of effective psychological care.     

Evolution or revolution? Adapting to complexity in wound management

Wound clinics are seeing an increase in the number of 'complex' wounds, which arise as the result of the interaction between multiple coexisting systemic pathologies, environmental factors and local wound factors. These complex wounds require an approach to diagnosis and management that can encapsulate all these factors. Unified wound assessment approaches such as HEIDI (History, Examination, Investigations, Diagnosis and management plan), wound bed preparation and applied wound management systems are essential to reach a definitive diagnosis and to ensure that management is agreed between the various clinical specialities that may be involved. A series of case histories is presented that illustrate the benefits of a unified approach to wound management. Results of a study into the cost-effectiveness of an improved foam dressing are presented, and the problems of demonstrating the ability to make long-term savings through short-term expenditure are discussed.     

Cost effectiveness of oral triptan therapy: a trans-national comparison based on a meta-analysis of randomised controlled trials

Objective: The objective of this study was to appraise the relative cost effectiveness of oral triptan therapy in the management of acute migraine, comparing the results obtained using drug cost data from six different countries, USA, UK, Canada, Germany, Italy and The Netherlands.

Method: A meta-analysis of randomised placebo controlled trials of single dose oral triptans was carried out in order to calculate aggregate Numbers Needed to Treat (NNT) for each triptan and dose. Cost effectiveness ratios were then derived for each treatment by applying mean drug acquisition costs for each country to these NNTs. Using a graphical plot for each country, incremental cost effectiveness comparisons were then made versus sumatriptan 100mg, the most commonly used oral triptan.

Results: When analysed in terms of 2-h pain

free outcomes, rizatriptan 10mg and eletriptan 40 and 80?mg were the most effective oral triptans. Rizatriptan 10mg has the most advantageous absolute cost effectiveness ratio in all six countries studied, although levels of statistical significance compared to other agents varied from one country to another. When compared to sumatriptan 100mg, rizatriptan 10mg and eletriptan 40?mg are most consistently the cost effective treatment choices, both being cost dominant in five out of six countries studied.

Conclusions: There are systematic differences in triptan efficacy that have an impact on treatment choice. Differences in pricing structure between countries mean that hierarchies of cost effectiveness will vary. Country-specific data should therefore be examined before defining treatment strategies.