Reporting of statistical results in prosthodontic and implantology journals: p values or confidence intervals?

PURPOSE Confidence intervals (CIs) are integral to the interpretation of the precision and clinical relevance of research findings. The aim of this study was to ascertain the frequency of reporting of CIs in leading prosthodontic and dental implantology journals and to explore possible factors associated with improved reporting. MATERIALS AND METHODS Thirty issues of nine journals in prosthodontics and implant dentistry were accessed, covering the years 2005 to 2012: The Journal of Prosthetic Dentistry, Journal of Oral Rehabilitation, The International Journal of Prosthodontics, The International Journal of Periodontics & Restorative Dentistry, Clinical Oral Implants Research, Clinical Implant Dentistry and Related Research, The International Journal of Oral & Maxillofacial Implants, Implant Dentistry, and Journal of Dentistry. Articles were screened and the reporting of CIs and P values recorded. Other information including study design, region of authorship, involvement of methodologists, and ethical approval was also obtained. Univariable and multivariable logistic regression was used to identify characteristics associated with reporting of CIs. RESULTS Interrater agreement for the data extraction performed was excellent (kappa = 0.88; 95% CI: 0.87 to 0.89). CI reporting was limited, with mean reporting across journals of 14%. CI reporting was associated with journal type, study design, and involvement of a methodologist or statistician. CONCLUSIONS Reporting of CI in implant dentistry and prosthodontic journals requires improvement. Improved reporting will aid appraisal of the clinical relevance of research findings by providing a range of values within which the effect size lies, thus giving the end user the opportunity to interpret the results in relation to clinical practice.

The reporting quality of randomized controlled trials in orthodontics.

OBJECTIVES Accurate 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. METHODS The 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. RESULTS 128 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. CONCLUSION The 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.

Active implementation strategy of CONSORT adherence by a dental specialty journal improved randomized clinical trial reporting.

OBJECTIVE To describe a novel CONsolidated Standards of Reporting Trials (CONSORT) adherence strategy implemented by the American Journal of Orthodontics and Dentofacial Orthopedics (AJO-DO) and to report its impact on the completeness of reporting of published trials. STUDY DESIGN AND SETTING The AJO-DO CONSORT adherence strategy, initiated in June 2011, involves active assessment of randomized clinical trial (RCT) reporting during the editorial process. The completeness of reporting CONSORT items was compared between trials submitted and published during the implementation period (July 2011 to September 2013) and trials published between August 2007 and July 2009. RESULTS Of the 42 RCTs submitted (July 2011 to September 2013), 23 were considered for publication and assessed for completeness of reporting, seven of which were eventually published. For all published RCTs between 2007 and 2009 (n = 20), completeness of reporting by CONSORT item ranged from 0% to 100% (Median = 40%, interquartile range = 60%). All published trials in 2011-2013, reported 33 of 37 CONSORT (sub) items. Four CONSORT 2010 checklist items remained problematic even after implementation of the adherence strategy: changes to methods (3b), changes to outcomes (6b) after the trial commenced, interim analysis (7b), and trial stopping (14b), which are typically only reported when applicable. CONCLUSION Trials published following implementation of the AJO-DO CONSORT adherence strategy completely reported more CONSORT items than those published or submitted previously.

Assessing the reporting quality in abstracts of randomized controlled trials in leading journals of oral implantology.

AIM Abstracts of randomized clinical trials are extremely important as trial appraisal is often based on the information included here. The objective of this study was to assess the quality of the reporting of RCT abstracts in journals of Oral Implantology. MATERIAL AND METHODS Six leading Implantology journals were screened for RCTs between years 2008 and 2012. A 21-item modified CONSORT for abstracts checklist was used to examine the completeness of abstract reporting. Descriptive statistics and linear regression modeling were employed for data analysis. RESULTS One hundred and sixty three RCT abstracts were included in this study. The majority of the RCTs were published in the Clinical Oral Implants Research (42.9%). The mean overall reporting quality score was 58.6% (95% CI: 57.6-59.7). The highest score was noted in the European Journal of Oral Implantology (63.8%; 95% CI: 61.8-65.8). Multivariate analysis demonstrated that abstract quality score was related to publication journal and number of research centers involved. Most abstracts adequately reported interventions (89.0%), objectives (77.9%) and conclusions (74.8%) while failed to report randomization procedures, allocation concealment, effect estimate, confidence intervals, and funding. Registration of RCTs was not reported in any of the abstracts. CONCLUSIONS The reporting quality in abstracts of RCTs published in Oral Implantology journals needs to be improved. Editors and authors should be encouraged to endorse the CONSORT for abstracts guidelines in order to achieve optimal quality in abstract reporting.

Prophylactic use of bevacizumab to avoid anterior segment neovascularization following proton therapy for uveal melanoma.

PURPOSE To investigate whether the prophylactic use of bevacizumab reduces the rate of rubeosis after proton therapy for uveal melanoma and improves the possibility to treat ischemic, reapplicated retina with laser photocoagulation. DESIGN Comparative retrospective case series. METHODS Uveal melanoma patients with ischemic retinal detachment and treated with proton therapy were included in this institutional study. Twenty-four eyes received prophylactic intravitreal bevacizumab injections and were compared with a control group of 44 eyes without bevacizumab treatment. Bevacizumab injections were performed at the time of tantalum clip insertion and were repeated every 2 months during 6 months, and every 3 months thereafter. Ultra-widefield angiography allowed determination of the extent of retinal ischemia, which was treated with laser photocoagulation after retinal reapplication. Main outcome measures were the time to rubeosis, the time to retinal reattachment, and the time to laser photocoagulation of ischemic retina. RESULTS Baseline characteristics were balanced between the groups, except for thicker tumors and larger retinal detachments in the bevacizumab group, potentially to the disadvantage of the study group. Nevertheless, bevacizumab prophylaxis significantly reduced the rate of iris rubeosis from 36% to 4% (log-rank test P = .02) and tended to shorten the time to retinal reapplication until laser photocoagulation of the nonperfusion areas could be performed. CONCLUSIONS Prophylactic intravitreal bevacizumab in patients treated with proton therapy for uveal melanoma with ischemic retinal detachment prevented anterior segment neovascularization, until laser photocoagulation to the reapplied retina could be performed.

Attitudes and Beliefs of Pig Farmers and Wild Boar Hunters Towards Reporting of African Swine Fever in Bulgaria, Germany and the Western Part of the Russian Federation

This study investigated the attitudes and beliefs of pig farmers and hunters in Germany, Bulgaria and the western part of the Russian Federation towards reporting suspected cases of African swine fever (ASF). Data were collected using a web-based questionnaire survey targeting pig farmers and hunters in these three study areas. Separate multivariable logistic regression models identified key variables associated with each of the three binary outcome variables whether or not farmers would immediately report suspected cases of ASF, whether or not hunters would submit samples from hunted wild boar for diagnostic testing and whether or not hunters would report wild boar carcasses. The results showed that farmers who would not immediately report suspected cases of ASF are more likely to believe that their reputation in the local community would be adversely affected if they were to report it, that they can control the outbreak themselves without the involvement of veterinary services and that laboratory confirmation would take too long. The modelling also indicated that hunters who did not usually submit samples of their harvested wild boar for ASF diagnosis, and hunters who did not report wild boar carcasses are more likely to justify their behaviour through a lack of awareness of the possibility of reporting. These findings emphasize the need to develop more effective communication strategies targeted at pig farmers and hunters about the disease, its epidemiology, consequences and control methods, to increase the likelihood of early reporting, especially in the Russian Federation where the virus circulates

Comparison of noninferiority margins reported in protocols and publications showed incomplete and inconsistent reporting.

OBJECTIVES To compare noninferiority margins defined in study protocols and trial registry records with margins reported in subsequent publications. STUDY DESIGN AND SETTING Comparison of protocols of noninferiority trials submitted 2001 to 2005 to ethics committees in Switzerland and The Netherlands with corresponding publications and registry records. We searched MEDLINE via PubMed, the Cochrane Controlled Trials Register (Cochrane Library issue 01/2012), and Google Scholar in September 2013 to identify published reports, and the International Clinical Trials Registry Platform of the World Health Organization in March 2013 to identify registry records. Two readers recorded the noninferiority margin and other data using a standardized data-abstraction form. RESULTS The margin was identical in study protocol and publication in 43 (80%) of 54 pairs of study protocols and articles. In the remaining pairs, reporting was inconsistent (five pairs, 9%), or the noninferiority margin was either not reported in the publication (five pairs, 9%) or not defined in the study protocol (one pair). The confidence interval or the exact P-value required to judge whether the result was compatible with noninferior, inferior, or superior efficacy was reported in 43 (80%) publications. Complete and consistent reporting of both noninferiority margin and confidence interval (or exact P-value) was present in 39 (72%) protocol-publication pairs. Twenty-nine trials (54%) were registered in trial registries, but only one registry record included the noninferiority margin. CONCLUSION The reporting of noninferiority margins was incomplete and inconsistent with study protocols in a substantial proportion of published trials, and margins were rarely reported in trial registries.

Reporting standards for studies of diagnostic test accuracy in dementia: The STARDdem Initiative.

OBJECTIVE To provide guidance on standards for reporting studies of diagnostic test accuracy for dementia disorders. METHODS An international consensus process on reporting standards in dementia and cognitive impairment (STARDdem) was established, focusing on studies presenting data from which sensitivity and specificity were reported or could be derived. A working group led the initiative through 4 rounds of consensus work, using a modified Delphi process and culminating in a face-to-face consensus meeting in October 2012. The aim of this process was to agree on how best to supplement the generic standards of the STARD statement to enhance their utility and encourage their use in dementia research. RESULTS More than 200 comments were received during the wider consultation rounds. The areas at most risk of inadequate reporting were identified and a set of dementia-specific recommendations to supplement the STARD guidance were developed, including better reporting of patient selection, the reference standard used, avoidance of circularity, and reporting of test-retest reliability. CONCLUSION STARDdem is an implementation of the STARD statement in which the original checklist is elaborated and supplemented with guidance pertinent to studies of cognitive disorders. Its adoption is expected to increase transparency, enable more effective evaluation of diagnostic tests in Alzheimer disease and dementia, contribute to greater adherence to methodologic standards, and advance the development of Alzheimer biomarkers.

Aspiration Thrombectomy for Treatment of ST-segment Elevation Myocardial Infarction: a Meta-analysis of 26 Randomized Trials in 11 943 Patients.

INTRODUCTION AND OBJECTIVES There is continued debate about the routine use of aspiration thrombectomy in patients with ST-segment elevation myocardial infarction. Our aim was to evaluate clinical and procedural outcomes of aspiration thrombectomy-assisted primary percutaneous coronary intervention compared with conventional primary percutaneous coronary intervention in patients with ST-segment elevation myocardial infarction. METHODS We performed a meta-analysis of 26 randomized controlled trials with a total of 11 943 patients. Clinical outcomes were extracted up to maximum follow-up and random effect models were used to assess differences in outcomes. RESULTS We observed no difference in the risk of all-cause death (pooled risk ratio = 0.88; 95% confidence interval, 0.74-1.04; P = .124), reinfarction (pooled risk ratio = 0.85; 95% confidence interval, 0.67-1.08; P = .176), target vessel revascularization (pooled risk ratio = 0.86; 95% confidence interval, 0.73-1.00; P = .052), or definite stent thrombosis (pooled risk ratio = 0.76; 95% confidence interval, 0.49-1.16; P = .202) between the 2 groups at a mean weighted follow-up time of 10.4 months. There were significant reductions in failure to reach Thrombolysis In Myocardial Infarction 3 flow (pooled risk ratio = 0.70; 95% confidence interval, 0.60-0.81; P < .001) or myocardial blush grade 3 (pooled risk ratio = 0.76; 95% confidence interval, 0.65-0.89; P = .001), incomplete ST-segment resolution (pooled risk ratio = 0.72; 95% confidence interval, 0.62-0.84; P < .001), and evidence of distal embolization (pooled risk ratio = 0.61; 95% confidence interval, 0.46-0.81; P = .001) with aspiration thrombectomy but estimates were heterogeneous between trials. CONCLUSIONS Among unselected patients with ST-segment elevation myocardial infarction, aspiration thrombectomy-assisted primary percutaneous coronary intervention does not improve clinical outcomes, despite improved epicardial and myocardial parameters of reperfusion. Full English text available from:www.revespcardiol.org/en.

Strengthening the Reporting of Observational Studies in Epidemiology for respondent-driven sampling studies: "STROBE-RDS" statement.

OBJECTIVES Respondent-driven sampling (RDS) is a new data collection methodology used to estimate characteristics of hard-to-reach groups, such as the HIV prevalence in drug users. Many national public health systems and international organizations rely on RDS data. However, RDS reporting quality and available reporting guidelines are inadequate. We carried out a systematic review of RDS studies and present Strengthening the Reporting of Observational Studies in Epidemiology for RDS Studies (STROBE-RDS), a checklist of essential items to present in RDS publications, justified by an explanation and elaboration document. STUDY DESIGN AND SETTING We searched the MEDLINE (1970-2013), EMBASE (1974-2013), and Global Health (1910-2013) databases to assess the number and geographical distribution of published RDS studies. STROBE-RDS was developed based on STROBE guidelines, following Guidance for Developers of Health Research Reporting Guidelines. RESULTS RDS has been used in over 460 studies from 69 countries, including the USA (151 studies), China (70), and India (32). STROBE-RDS includes modifications to 12 of the 22 items on the STROBE checklist. The two key areas that required modification concerned the selection of participants and statistical analysis of the sample. CONCLUSION STROBE-RDS seeks to enhance the transparency and utility of research using RDS. If widely adopted, STROBE-RDS should improve global infectious diseases public health decision making.

Disclosing and reporting medical errors: Cross-sectional survey of Swiss anaesthesiologists.

BACKGROUND There is limited research on anaesthesiologists' attitudes and experiences regarding medical error communication, particularly concerning disclosing errors to patients. OBJECTIVE To characterise anaesthesiologists' attitudes and experiences regarding disclosing errors to patients and reporting errors within the hospital, and to examine factors influencing their willingness to disclose or report errors. DESIGN Cross-sectional survey. SETTING Switzerland's five university hospitals' departments of anaesthesia in 2012/2013. PARTICIPANTS Two hundred and eighty-one clinically active anaesthesiologists. MAIN OUTCOME MEASURES Anaesthesiologists' attitudes and experiences regarding medical error communication. RESULTS The overall response rate of the survey was 52% (281/542). Respondents broadly endorsed disclosing harmful errors to patients (100% serious, 77% minor errors, 19% near misses), but also reported factors that might make them less likely to actually disclose such errors. Only 12% of respondents had previously received training on how to disclose errors to patients, although 93% were interested in receiving training. Overall, 97% of respondents agreed that serious errors should be reported, but willingness to report minor errors (74%) and near misses (59%) was lower. Respondents were more likely to strongly agree that serious errors should be reported if they also thought that their hospital would implement systematic changes after errors were reported [(odds ratio, 2.097 (95% confidence interval, 1.16 to 3.81)]. Significant differences in attitudes between departments regarding error disclosure and reporting were noted. CONCLUSION Willingness to disclose or report errors varied widely between hospitals. Thus, heads of department and hospital chiefs need to be aware of the importance of local culture when it comes to error communication. Error disclosure training and improving feedback on how error reports are being used to improve patient safety may also be important steps in increasing anaesthesiologists' communication of errors.

Age- and Gender-related Disparities in Primary Percutaneous Coronary Interventions for Acute ST-segment elevation Myocardial Infarction.

BACKGROUND Previous analyses reported age- and gender-related differences in the provision of cardiac care. The objective of the study was to compare circadian disparities in the delivery of primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) according to the patient's age and gender. METHODS We investigated patients included into the Acute Myocardial Infarction in Switzerland (AMIS) registry presenting to one of 11 centers in Switzerland providing primary PCI around the clock, and stratified patients according to gender and age. FINDINGS A total of 4723 patients presented with AMI between 2005 and 2010; 1319 (28%) were women and 2172 (54%) were ≥65 years of age. More than 90% of patients <65 years of age underwent primary PCI without differences between gender. Elderly patients and particularly women were at increased risk of being withheld primary PCI (males adj. HR 4.91, 95% CI 3.93-6.13; females adj. HR 9.31, 95% CI 7.37-11.75) as compared to males <65 years of age. An increased risk of a delay in door-to-balloon time >90 minutes was found in elderly males (adj HR 1.66 (95% CI 1.40-1.95), p<0.001) and females (adj HR 1.57 (95% CI 1.27-1.93), p<0.001), as well as in females <65 years (adj HR 1.47 (95% CI 1.13-1.91), p = 0.004) as compared to males <65 years of age, with significant differences in circadian patterns during on- and off-duty hours. CONCLUSIONS In a cohort of patients with AMI in Switzerland, we observed discrimination of elderly patients and females in the circadian provision of primary PCI.