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Objective: The aim of this study is to provide an update as to whether authors in the orthodontic field of research currently report randomized clinical trials (RCTs) adequately as defined by the Consolidated Standards of Reporting Trials (CONSORT) statement. Methods: The American Journal of Orthodontics and Dentofacial Orthopedics (AJO-DO), Journal of Orthodontics (JO), European Journal of Orthodontics (EJO) and Angle Orthodontist (AO) were reviewed to identify all articles that reported RCTs published between January 2008 and June 2012.Reports were scored using the CONSORT 37 item checklist. A 10% random sample of the papers was scored by a second examiner to assess inter-examiner reliability of the CONSORT score. Another 10% random sample of the papers was scored a second time by the first examiner 3 months after initial data collection to test intra-examiner reliability. Results: A total of 151 clinical trial reports have been identified out of 3335 articles in the four journals from January 2008 to June 2012.Mean CONSORT score of the four journals was 51.7%. Journal of Orthodontics achieved the highest score of 73.6% and the lowest score was achieved by AO with a score of 44.5%. Overall compliance with CONSORT increased from 47.8 to 56.3% between 2008 and 2012. Conclusion: Clinical trials reports represented < 5% of articles in the four main orthodontic journals between 2008 and 2012. • CONSORT mean score ranged from 44.5 to 73.6% between journals. • CONSORT mean score increased through the period of investigation. [ABSTRACT FROM AUTHOR]

Objectives: To identify the adherence interventions used with people receiving treatments to prevent or manage scarring, the effectiveness of these interventions, and the theoretical frameworks on which these interventions were based. Data sources: Databases (PubMed, Embase, Web of Science, CINAHL, PsychINFO and OTseeker) were searched (09.10.2020) with no date or language restrictions. Grey literature databases, clinical trial registries and references lists of key papers were also searched. Review methods: Eligible randomised controlled trials included people using treatments for scarring following skin wounds, interventions that may improve adherence, and outcomes measuring adherence. Risk of bias (selection, performance, detection, attrition, reporting) and certainty of evidence (inconsistency, imprecision, indirectness, publication bias) were assessed. Results: Four randomised trials were included with 224 participants (17 children) with burn scars. Interventions involved educational (three trials) or technology-based components (four trials) and ranged in length from two weeks to six months. All four trials reported greater adherence rates in the intervention group compared with standard practice [standardised mean difference = 1.50 (95% confidence interval (CI) = 0.91–2.08); 2.01 (95% CI 1.05–2.98); odds ratio = 0.28 (95% CI = 0.11–0.69)]. One trial did not report original data. The certainty of evidence was very low. Conclusion: Adherence interventions using education or technology for people receiving burn scar treatment may improve adherence. Further studies are needed particularly in children, with a focus on including outcomes of importance to patients (e.g. quality of life) and identifying core components of effective adherence interventions using theoretical frameworks. [ABSTRACT FROM AUTHOR]

The article offers information on how can the quality of published research be enhanced. It mentions that research methodology workshops should devote an entire session for introducing research guidelines; and also mentions only a combination of strategies that target awareness, training, and sensitive enforcement can eventually enhance the quality of published research.

Objectives: To assess whether clinical trials published in the orthodontic literature comply with the Consolidated Standards of Reporting Trials (CONSORT) statement, and whether compliance has changed over time. Design: Retrospective study. Sample: Clinical trials published in four orthodontic journals (American Journal of Orthodontics and Dentofacial Orthopedics, Angle Orthodontist, European Journal of Orthodontics, and Journal of Orthodontics) at three time points [1995/6 (preCONSORT), 2000/I (post-CONSORT) and 2005/6 (post revised-CONSORT)]. Methods: Trials were scored using a 36-point checklist developed from the CONSORT statement. Each item on the checklist was scored as either included, not included, or not applicable if the trial design did not allow its inclusion. The proportion of trials describing randomization, allocation concealment, and blinding was also calculated. The mean scores were compared between time points and between journals. Results: A total of 151 reports were included. The mean score was 41.5% (SD 10.3). The mean post-CONSORT score was higher than the pre-CONSORT score (P=0.01; WMD, 5.73; 95% Cl, 1.64-9.82), and the mean post revised-CONSORT was also higher than the pre-CONSORT score (P=0.0l; WMD, 4.44; 95% Cl, 1.02-7.87). At the post revised-CONSORT time point, the mean score in the journals which had adopted the CONSORT statement was higher than for those which had not (P<0.001; chi square, 17.78; df=3). Reporting of randomization, allocation concealment and blinding was inadequate at all three time points. Conclusions: The reporting of clinical trials in the orthodontic literature has improved since the publication of the CONSORT statement, particularly in journals which have adopted the statement. However, the reporting of randomization, allocation concealment and blinding remains inadequate. [ABSTRACT FROM AUTHOR]

Background: In chronic obstructive pulmonary disease (COPD), both the time needed for patients to gain symptom improvement with long-acting bronchodilator therapy and whether an early response is predictive of a sustained response is unknown. This study aimed to investigate how quickly meaningful symptom responses are seen in patients with COPD with bronchodilator therapy and whether these responses are sustained. Methods: Early MAXimisation of bronchodilation for improving COPD stability (EMAX) was a 24-week, double-blind, double-dummy, parallel-group trial that randomised patients to umeclidinium/vilanterol (UMEC/VI), umeclidinium or salmeterol. Daily Evaluating Respiratory Symptoms in COPD (E-RS:COPD) score and rescue salbutamol use were captured via an electronic diary and analysed initially in 4-weekly periods. Post hoc analyses assessed change from baseline in daily E-RS:COPD score and rescue medication use weekly (Weeks 1–8), and association between E-RS:COPD responder status at Weeks 1–4 and later time points. Results: In the intent-to-treat population (n = 2425), reductions from baseline in E-RS:COPD scores and rescue medication use were apparent from Day 2 with all treatments. Treatment differences for UMEC/VI versus either monotherapy plateaued by Week 4–8 and were sustained at Weeks 21–24; improvements were consistently greater with UMEC/VI. For all treatments, most patients (60–85%) retained their Weeks 1–4 E-RS:COPD responder/non-responder status at Weeks 21−24. Among patients receiving UMEC/VI who were E-RS:COPD responders at Weeks 1–4, 70% were responders at Weeks 21–24. Conclusion: Patients with symptomatic COPD had greater potential for early symptom improvements with UMEC/VI versus either monotherapy. This benefit was generally maintained for 24 weeks. Early monitoring of treatment response can provide clinicians with an early indication of a patient's likely longer-term response to prescribed bronchodilator treatment and will facilitate appropriate early adjustments in care. Clinical Trial Registration: NCT03034915, 2016-002513-22 (EudraCT Number). The reviews of this paper are available via the supplemental material section. [ABSTRACT FROM AUTHOR]

This letter to the editor responds to a study on the effectiveness of an Erector Spinae Plane Block (ESPB) in reducing opioid consumption and pain in patients undergoing minimally invasive posterior stabilization. The authors of the letter raise concerns about the study's methodology, including the absence of study registration and the lack of adherence to reporting guidelines. They also question the accuracy and interpretation of the visual analogue scale (VAS) measurements used in the study. Ultimately, the authors disagree with the conclusions drawn by the original study and suggest a more valid conclusion would be that there were no statistically significant differences in opioid consumption and VAS for pain during the first 48 hours after surgery. [Extracted from the article]

As cases of coronavirus 2019 (COVID-19) keep rising, reported deaths are increasing. Public health measures have been implemented with mixed efficacy. As vaccines are becoming more widely available and accessible globally, treating critically ill COVID-19 patients remains an issue with only dexamethasone found to be therapeutically effective to date. However, trials studying the efficacy of IL-6 inhibitors, namely tocilizumab have been underway with promising results. This paper is a narrative review that aims to review the current evidence provided by randomized clinical trials (RCT) for the use of tocilizumab in COVID-19. Electronic database searches were carried out in Medline, PubMed, Embase, Google Scholar, and ongoing clinical trial registries with the period set from January 1, 2020 to February 20, 2021. Prepublication manuscripts were found using the pre-print repository medRxiv. Keywords included "COVID-19,""coronavirus,""SARS-CoV-2,""sepsis,""pneumonia,""cytokine storm,""cytokine release syndrome,""IL-6 inhibitors," and "tocilizumab," as exact phrases, and a combination of subject headings according to databases syntax. Only trials with a clear and well-defined methodology, at least 100 patients recruited, and which have had results published either after peer review or in pre-print were included. In hospitalized patients with severe COVID-19, who are hypoxic and have a CRP ≥ 75 mg/L, the current evidence favors the use of a combination of tocilizumab and corticosteroids to reduce mortality, among other clinical benefits. There is also overwhelming evidence of the good safety profile of tocilizumab with only few cases of neutropenia reported with a decrease in infection rates. Tocilizumab is currently thought to work through the inhibition of IL-6 receptors (IL-6R), preventing downstream activation of pro-inflammatory reactions and cytokine release syndrome. [ABSTRACT FROM AUTHOR]

Background and objectives: To carry out a cross-sectional survey of the medical literature on laboratory research papers published later than 2012 and available in the common search engines (PubMed, Google Scholar) on the quality of statistical reporting of method comparison studies using Bland–Altman (B-A) analysis. Methods:Fifty clinical studies were identified which had undertaken method comparison of laboratory analytes using B-A. The reporting of B-A was evaluated using a predesigned checklist with following six items: (1) correct representation of x-axis on B-A plot, (2) representation and correct definition of limits of agreement (LOA), (3) reporting of confidence interval (CI) of LOA, (4) comparison of LOA with a priori defined clinical criteria, (5) evaluation of the pattern of the relationship between difference (y-axis) and average (x-axis) and (6) measures of repeatability.Results and interpretation:The x-axis and LOA were presented correctly in 94%, comparison with a priori clinical criteria in 74%, CI reporting in 6%, evaluation of pattern in 28% and repeatability assessment in 38% of studies.Conclusions: There is incomplete reporting of B-A in published clinical studies. Despite its simplicity, B-A appears not to be completely understood by researchers, reviewers and editors of journals. There appear to be differences in the reporting of B-A between laboratory medicine journals and other clinical journals. A uniform reporting of B-A method will enhance the generalizability of results. [ABSTRACT FROM PUBLISHER]

Background: Gender-based violence (GBV) is a major public health concern and a human rights issue disproportionately affecting disabled women. Disabled women are twice as likely to experience GBV than nondisabled women, yet there has been a lack of attention to this issue. This review aims to gain a greater understanding of the experiences of GBV of disabled women through a systematic and qualitative meta-synthesis. The qualitative meta-synthesis will be conducted by a research team of academic and community members and students with varying lived and service provider experiences with disabilities and GBV. The study findings aim to promote best practices by offering solutions to increase accessible and inclusive resources and services responsive to disabled women. Methods: A systematic review of qualitative studies will be performed based on searches of 12 academic databases, including MEDLINE (Ovid), APA PsycINFO (EBSCO), Sociological Abstracts (ProQuest), Social Services Abstracts (ProQuest), and SocINDEX (EBSCO). A search of the gray literature will be performed by searching the Google search engine, Google Scholar, the Community Health Online Digital Archive and Research Resource (CHODARR), and the Global Database on Violence Against Women. In addition to the database and gray literature searching, we will complete backward and forward citation tracing. Two research team members will be involved in all screening, review, data extraction, and quality assessment of studies. A third reviewer will resolve any disagreements and consult with the research team. Thematic synthesis steps will include becoming familiar with the data, developing a thematic framework, indexing the data to identify themes and codes, charting the data, and mapping and interpreting the data. The Critical Appraisal Skills Programme checklist will be used to appraise the quality of included studies. Confidence in the meta-synthesis findings will be assessed by applying the GRADECERQual approach. Review Registration: This protocol is registered with the International Prospective Register of Systematic Reviews (PROSPERO): CRD42023400410. [ABSTRACT FROM AUTHOR]

We have investigated the effectiveness of three noise-reduction algorithms, namely an adaptive monaural beamformer (MB), a fixed binaural beamformer (BB), and a single-microphone stationary-noise reduction algorithm (SNRA) by assessing the speech reception threshold (SRT) in a group of 15 bimodal cochlear implant users. Speech was presented frontally towards the listener and background noise was established as a homogeneous field of long-term speech-spectrum-shaped (LTSS) noise or 8-talker babble. We pursued four research questions, namely: whether the benefits of beamforming on the SRT differ between LTSS noise and 8-talker babble; whether BB is more effective than MB; whether SNRA improves the SRT in LTSS noise; and whether the SRT benefits of MB and BB are comparable to their improvement of the signal-to-noise ratio (SNR). The results showed that MB and BB significantly improved SRTs by an average of 2.6 dB and 2.9 dB, respectively. These benefits did not statistically differ between noise types or between the two beamformers. By contrast, physical SNR improvements obtained with a manikin revealed substantially greater benefits of BB (6.6 dB) than MB (3.3 dB). SNRA did not significantly affect SRTs per se in omnidirectional microphone settings, nor in combination with MB and BB. We conclude that in the group of bimodal listeners tested, BB had no additional benefits on speech recognition over MB in homogeneous noise, despite the finding that BB had a substantial larger benefit on the SNR than MB. SNRA did not improve speech recognition. [ABSTRACT FROM AUTHOR]

Famous trials not only generate immense popularity and intrigue, they also have the power to change history. Surprisingly, little research examines the use of complex language during these culturally-significant trial outcomes. In the present study, we helped fill in this gap by evaluating the relationship between attorneys' use of integratively complex language and trial outcomes. Using the well-validated Automated Integrative Complexity scoring system, we analyzed the complexity of language in the opening and closing statements of famous trials. We found that higher levels of integrative complexity led to a significant increase in winning outcomes, but only for the prosecution. Further, this effect was driven by elaborative forms of complexity and not dialectical forms of complexity. Taken together, these results fill a large gap in our understanding of how language might influence the outcomes of culturally-significant legal proceedings. [ABSTRACT FROM AUTHOR]

The Italian National Statistical Institute (Istat) is currently engaged in a modernization programme that foresees a significant revision of the methods traditionally used for the production of official statistics. The main concept behind this transformation is the use of the Integrated System Statistical Registers, created by a massive integration of administrative archives and survey data. In this article, we focus on how to measure the accuracy of register estimates of a population total from measurements calculated at the unit level. We propose the global mean squared error (GMSE) as a statistical quantity suitable for measuring accuracy in the context of the production of official statistics. It can be defined to explicitly consider the main sources of uncertainty that may affect registers. The article suggests a feasible calculation strategy for the GMSE that allows National Statistical Institutes to build algorithms that can promptly be applied for each user request, thus improving the relevance, transparency and confidence of official statistics. Through a simulation study, we verified the efficacy of the proposed strategy. [ABSTRACT FROM AUTHOR]

Background: Enhancing detection of unrecognized atrial fibrillation among acute ischemic stroke patients is crucial for secondary stroke prevention. Aim: To evaluate whether the detection rate of new atrial fibrillation in acute ischemic stroke patients without known atrial fibrillation could be improved by doing serial 12-lead electrocardiograms once daily for five days, compared with conventional 24-h Holter monitoring (24-h Holter). Methods: We conducted a randomized clinical trial to compare the detection rates of paroxysmal atrial fibrillation between serial electrocardiograms versus 24-h Holter from October 2015 to October 2018 at six hospitals. Eligible participants were acute ischemic stroke patients with aged ≥65 years, with neither atrial fibrillation history nor any presence of atrial fibrillation on baseline electrocardiogram at admission. The primary outcome was newly detected electrocardiogram in the serial electrocardiograms and 24-h Holter group. Results: Among 826 patients, baseline characteristics were similar between both groups. In the intention-to-treat analysis, there was no statistical difference between serial electrocardiograms versus 24-Holter to detect atrial fibrillation (8.4% vs. 6.9%; adjusted odds ratio 1.17, 95% confidence interval 0.69–2.01). Stepwise multivariate logistic regression revealed age ≥80 years and history of heart failure were associated with detection of paroxysmal atrial fibrillation whereas patients with lacunar infarction had lower odds for detection of paroxysmal atrial fibrillation. Conclusions: Serial electrocardiograms had comparable detection rate of paroxysmal atrial fibrillation compared with 24-h Holter and might be a viable alternative to 24-h Holter as a first-line approach to survey for potential paroxysmal atrial fibrillation among elderly patients with acute ischemic stroke. Clinical Trial Registration: URL https://clinicaltrials.gov/ct2/show/NCT02578979 Unique Identifiers: NCT02578979 [ABSTRACT FROM AUTHOR]

Background and aims: The structured, simplified modified Rankin scale questionnaire (smRSq) may increase reliability over the interrogative approach to scoring the modified Rankin scale (mRS) in acute stroke research and practice. During the conduct of the alteplase-dose arm of the international ENhanced Control of Hypertension ANd Thrombolysis StrokE stuDy (ENCHANTED), we had an opportunity to compare each of these approaches to outcome measurement. Methods: Baseline demographic data were recorded together with the National Institutes of Health Stroke Scale (NIHSS). Follow-up measures obtained at 90 days included mRS, smRSq, and the 5-Dimension European Quality of life scale (EQ-5D). Agreements between smRSq and mRS were assessed with the Kappa statistic. Multiple logistic regression was used to identify baseline predictors of Day 90 smRSq and mRS scores. Treatment effects, based on Day 90 smRSq/mRS scores, were tested in logistic and ordinal logistic regression models. Results: SmRSq and mRS scores had good agreement (weighted Kappa 0.79, 95% confidence interval (CI) 0.78–0.81), while variables of age, atrial fibrillation, diabetes mellitus, pre-morbid mRS (1 vs. 0), baseline NIHSS scores, and imaging signs of cerebral ischemia, similarly predicted their scores. Odds ratios for death or disability, and ordinal shift, 90-day mRS scores using smRSq were 1.05 (95% CI 0.91–1.20; one-sided P = 0.23 for non-inferiority) and 0.98 (95% CI 0.87–1.11; P = 0.02 for non-inferiority), similar to those using mRS. Conclusions: This study demonstrates the utility of the smRSq in a large, ethnically diverse clinical trial population. Scoring of the smRSq shows adequate agreement with the standard mRS, thus confirming it is a reliable, valid, and useful alternative measure of functional status after acute ischemic stroke. Clinical Trial registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01422616. [ABSTRACT FROM AUTHOR]

Background and aims: Only a minority of patients with Embolic Stroke of Undetermined Source (ESUS) receive prolonged cardiac monitoring despite current recommendations. The identification of ESUS patients who have low probability of new diagnosis of atrial fibrillation (AF) could potentially support a strategy of more individualized allocation of available resources and hence, increase their diagnostic yield. We aimed to develop a tool that can identify ESUS patients who have low probability of new incident AF. Methods: We performed multivariate stepwise regression in a pooled dataset of consecutive ESUS patients from three prospective stroke registries to identify predictors of new incident AF. The coefficient of each independent covariate of the fitted multivariable model was used to generate an integer-based point scoring system. Results: Among 839 patients (43.1% women, median age 67.0 years) followed-up for a median of 24.3 months (2999 patient-years), 125 (14.9%) had new incident AF. The proposed score assigns 3 points for age ≥ 60 years; 2 points for hypertension; −1 point for left ventricular hypertrophy reported at echocardiography; 2 points for left atrial diameter >40 mm; −3 points for left ventricular ejection fraction <35%; 1 point for the presence of any supraventricular extrasystole recorded during all available 12-lead standard electrocardiograms performed during hospitalization for the ESUS; −2 points for subcortical infarct; −3 points for the presence of non-stenotic carotid plaques. The rate of new incident AF during follow-up was 1.97% among the 42.3% of the cohort who had a score of ≤0, compared to 26.9% in patients with > 0 (relative risk: 13.7, 95%CI: 5.9--31.5). The area under the curve of the score was 84.8% (95%CI: 79.9--86.9%). The sensitivity and negative predictive value of a score of ≤0 for new incident AF during follow-up were 94.9% (95%CI: 89.3--98.1%) and 98.0% (95%CI: 95.8--99.3%), respectively. Conclusions: The proposed AF-ESUS score has high sensitivity and high negative predictive value to identify ESUS patients who have low probability of new incident AF. Patients with a score of 1 or more may be better candidates for prolonged automated cardiac monitoring. Clinical trial registration: URL: https://www.clinicaltrials.gov/ Unique identifier: NCT02766205. [ABSTRACT FROM AUTHOR]

The objectives of this study were to assess the reporting quality and methodological quality of split-mouth trials (SMTs) published during the past 2 decades and to determine whether there has been an improvement in their quality over time. We searched the MEDLINE database via PubMed to identify SMTs published in 1998, 2008, and 2018. For each included SMT, we used the CONsolidated Standards Of Reporting Trials (CONSORT) 2010 guideline, CONSORT for within-person trial (WPT) extension, and a new 3-item checklist to assess its trial reporting quality (TRQ), WPT-specific reporting quality (WRQ), and SMT-specific methodological quality (SMQ), respectively. Multivariable generalized linear models were performed to analyze the quality of SMTs over time, adjusting for potential confounding factors. A total of 119 SMTs were included. The mean overall score for the TRQ (score range, 0 to 32), WRQ (0 to 15), and SMQ (0 to 3) was 15.77 (SD 4.51), 6.06 (2.06), and 1.12 (0.70), respectively. The primary outcome was clearly defined in only 28 SMTs (23.5%), and only 27 (22.7%) presented a replicable sample size calculation. Only 45 SMTs (37.8%) provided the rationale for using a split-mouth design. The correlation between body sites was reported in only 5 studies (4.2%) for sample size calculation and 4 studies (3.4%) for statistical results. Only 2 studies (1.7%) performed an appropriate sample size calculation, and 46 (38.7%) chose appropriate statistical methods, both accounting for the correlation among treatment groups and the clustering/multiplicity of measurements within an individual. Results of regression analyses suggested that the TRQ of SMTs improved significantly with time (P < 0.001), while there was no evidence of improvement in WRQ or SMQ. Both the reporting quality and methodological quality of SMTs still have much room for improvement. Concerted efforts are needed to improve the execution and reporting of SMTs. [ABSTRACT FROM AUTHOR]

Context: Placental pathology may be an important missing link in the causal pathway of perinatal stroke. The study aim was to systematically review the literature regarding the role of the placenta in perinatal stroke. MEDLINE, Embase, Scopus, and Web of Science electronic databases were searched from 2000 to 2019. Studies were selected based on predefined criteria. To enable comparisons, placental abnormalities were coded using Redline's classification. Results: Ten studies met the inclusion criteria. Less than a quarter of stroke cases had placental pathology reported. Placental abnormalities were more common among children with perinatal stroke than in the control group. The most frequent placental abnormality was Redline's category 2 (thrombo-inflammatory process). Conclusions: Placental abnormalities appear to be associated with perinatal stroke, supporting additional indirect evidence and biological plausibility of a causative role. However, the results should be interpreted cautiously considering the low frequency of placental examination and lack of uniformity in placental pathology reporting. Clinical Trial Registration: PROSPERO Registration no: CRD42017081256. [ABSTRACT FROM AUTHOR]

When results were analyzed, we found that the following five statements were indicated by the highest percentage of respondents as being important in determining study participation: (a) Purpose of the study, 56%; (b) Procedures of the study, 51%; (c) Amount of time participation takes, 38%; (d) Information about how data are protected, 32%; (e) Statement that participating is not part of your medical care, 32%. Finally, several yes/no questions were included that probed perceptions of fairness about when studies with tight timelines should be able to "jump ahead" and be reviewed more quickly: when it was your own study, a colleague's study, or a student/post-doc/trainee's study. Finally, investigators were divided about whether it would be fair for their own study, a colleague's study, or a student's study to jump ahead of other studies if they had a tight timeline (respectively, 52%, 58%, and 50% affirmative responses). In addition, this study did not compare how IRB members' assessment of the risks of a singular research procedure in isolation may differ from their assessment of the procedure in the context of a complete study protocol. [Extracted from the article]

There has been increasing interest in recent years in the possibility of increasing the efficiency of clinical trials by using historical controls. There has been a general recognition that in replacing concurrent by historical controls, the potential for bias is serious and requires some down-weighting to the apparent amount of historical information available. However, such approaches have generally assumed that what is required is some modification to the standard inferential model offered by the parallel group trial. In our opinion, the correct starting point that requires modification is a trial in which treatments are allocated to clusters. This immediately shows that the amount of information available is governed not just by the number of historical patients but also by the number of centres and of historical studies. Furthermore, once one accepts that external patients may be used as controls, this raises the issue as to which patients should be used. Thus, abandoning concurrent control has implications for many aspects of design and analysis of trials, including (a) identification, pre-specification and agreement on a suitable historical dataset; (b) an agreed, enforceable and checkable plan for recruiting the experimental arm; (c) a finalised analysis plan prior to beginning the trial and (d) use of a hierarchical model with sufficient complexity. We discuss these issues and suggest approaches to design and analysis making extensive reference to the partially randomised Therapeutic Arthritis Research and Gastrointestinal Event Trial study. We also compare some Bayesian and frequentist approaches and provide some important regulatory considerations. We conclude that effective use of historical data will require considerable circumspection and discipline. [ABSTRACT FROM AUTHOR]

Background: It is not always possible to verify whether a patient complaining of symptoms consistent with transient ischemic attack has had an actual cerebrovascular event. Research question: To characterize the risk of cardiovascular events associated with a history of stroke/transient ischemic attack in patients with atrial fibrillation. Study design and methods: This study investigated the clinical characteristics and outcomes of patients with a history of stroke/transient ischemic attack among 52,014 patients enrolled prospectively in GARFIELD-AF registry. The diagnosis of stroke or transient ischemic attack was not protocol defined but based on physicians' assessment. Patients' one-year risk of death, stroke/systemic embolism, and major bleeding was assessed by multivariable Cox regression. Results: At enrollment, 5617 (10.9%) patients were reported to have a history of stroke or transient ischemic attack. Patients with stroke or transient ischemic attack were older and had a greater burden of diabetes, moderate-to-severe kidney disease, and atherothrombosis and higher median CHA2DS2-VASc and HAS-BLED scores than those without history of stroke or transient ischemic attack. After adjustment, prior stroke/transient ischemic attack was associated with significantly higher risk for all-cause mortality (hazard ratio (HR), 1.26; 95% confidence interval (CI), 1.12–1.42), cardiovascular death (HR, 1.22; 95% CI, 1.01–1.48), non-cardiovascular death (HR, 1.39; 95% CI, 1.15–1.68), and stroke/systemic embolism (HR, 2.17; 95% CI, 1.80–2.63) than patients without history of stroke/transient ischemic attack. In patients with a prior stroke alone higher risk was observed for all-cause mortality (HR, 1.29; 95% CI, 1.11–1.50), non-cardiovascular death (HR, 1.39; 95% CI, 1.10–1.77), and stroke/systemic embolism (HR, 2.29; 95% CI, 1.83–2.86). No significantly elevated risk of adverse events was seen for patients with history of transient ischemic attack alone. Interpretation: A history of prior stroke or transient ischemic attack is a strong independent risk factor for mortality and stroke/systemic embolism. This excess risk is mainly attributed to a history of stroke (with or without transient ischemic attack), whereas history of transient ischemic attack is a weaker predictor. Clinical trial registration: NCT01090362. [ABSTRACT FROM AUTHOR]

Rationale: Recurrent stroke, cardiovascular morbidity, and mortality are important causes of poor outcome in patients with index stroke. Despite the availability of best medical management recurrent stroke occur in up to 15–20% of patients with stroke in India. Education for stroke prevention could be a strategy to prevent recurrent strokes. Hypothesis: We hypothesize that a structured semi-interactive stroke prevention package can reduce the risk of recurrent strokes, acute coronary artery syndrome, and death in patients with sub-acute stroke at the end of one year. Design: Secondary Prevention by Structured Semi-Interactive Stroke Prevention Package in INDIA (SPRINT INDIA) is a multi-center stroke trial involving 25 centers under the Indian Stroke Clinical Trial Network. Patients with first ever sub-acute stroke within two days to three months of onset, age 18–85 years, mRS <5, showing recent stroke in imaging are included. Participants or caregivers able to read and complete tasks suggested in a stroke prevention workbook and have a cellular device for receiving short message service and watching videos. A total of 5830 stroke patients speaking 11 different languages are being randomized to intervention or control arm. Patients in the intervention arm are receiving a stroke prevention workbook, regular educational short messages, and videos. All patients in the control arm are receiving standard of care management. Summary: Structured semi-interactive stroke prevention package may reduce the risk of recurrent strokes, acute coronary artery syndrome, and death in patients with sub-acute stroke. Trial registration: This trial is registered with clinicaltrials.gov (NCT03228979) and CTRI (Clinical Trial Registry India; CTRI/2017/09/009600). [ABSTRACT FROM AUTHOR]

The aim of the study was to investigate an ultrasound-guided posterior antebrachial cutaneous nerve block based on visualising the nerve within the fat-filled flat tunnel and describe the area of cutaneous sensory loss. A total of 12 healthy volunteers were included in the study. The posterior antebrachial cutaneous nerve was identified within the fat-filled flat tunnel in the upper arm using high-frequency ultrasound. The nerve was blocked using an in-plane needle guidance technique with 1 ml 2% lidocaine. Sensory loss to pinprick was evaluated 15 minutes after performing the block and the cutaneous sensory block area mapped. Ultrasound visualisation of the posterior antebrachial cutaneous nerve in the fat-filled flat tunnel was possible in all volunteers. The median distance of the posterior antebrachial cutaneous nerve to the lateral epicondyle of the elbow was 67.5 (range 54-105) mm. Loss of sharpness sensation to pinprick extended from the posterior aspect of the distal upper arm and posterior forearm to the wrist. The median cutaneous sensory block area was 103 (range 61-341) cm². Two volunteers had a sensory block over the anterior forearm of 29 and 10 cm² respectively. This amounted to 11% and 4.5% of the total cutaneous sensory block area. One volunteer had a sensory block over the dorsum of the hand of 39 cm² (15% of the total cutaneous sensory block area). The results of this study indicate that the fat-filled flat tunnel can be a useful sono-anatomical landmark in identifying the posterior antebrachial cutaneous nerve and may serve as a target for injection. Although sensory block is predominantly confined to the posterior distal arm and forearm, inter-individual variability in the area and distribution was observed. Sensory block in the anterior forearm and dorsum of the hand can occur. The study was prospectively registered at the Australian New Zealand Clinical Trials Registry, identifier ACTRN12618000891224. [ABSTRACT FROM AUTHOR]

Background: Randomized controlled trials provide high-level evidence, but the necessity to include selected patients may limit the generalisability of their results. Methods: Comparisons were made of baseline and outcome data between patients with acute ischemic stroke (AIS) recruited into the alteplase-dose arm of the international, multi-center, Enhanced Control of Hypertension and Thrombolysis Stroke study (ENCHANTED) in the United Kingdom (UK), and alteplase-treated AIS patients registered in the UK Sentinel Stroke National Audit Programme (SSNAP) registry, over the study period June 2012 to October 2015. Results: There were 770 AIS patients (41.2% female; mean age 72 years) included in ENCHANTED at sites in England and Wales, which was 19.5% of alteplase-treated AIS patients registered in the SSNAP registry. Trial participants were significantly older, had lower baseline neurological severity, less likely Asian, and had more premorbid symptoms, hypertension and atrial fibrillation. Although ENCHANTED participants had higher rates of symptomatic intracerebral hemorrhage than those in SSNAP, there were no differences in onset-to-treatment time, levels of disability (assessed by the modified Rankin scale) at hospital discharge, and mortality over 90 days between groups. Conclusions: Despite the high level of participation, equipoise over the dose of alteplase among UK clinician investigators favored the inclusion of older, frailer, milder AIS patients in the ENCHANTED trial. Clinical trial registration: Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01422616 [ABSTRACT FROM AUTHOR]

Background: Use of various bone graft substitutes are advised to prevent bone loss, periodontal problems, and enhance bone formation after surgical removal of the mandibular third molar. Choice of graft substitute depends on biological properties and the cost of the material. So, a preliminary study was planned to evaluate and compare the effectiveness of eggshell-derived nano-hydroxyapatite as an emerging graft substitute for the enhancement of bone regeneration. Materials and methods: Twelve patients (out of 20 enrolled) were finally assessed for bone healing after surgical removal of bilateral mandibular third molars in a split-mouth randomized controlled clinical study. All of them were assessed and compared at baseline, first, third, and sixth month. Clinically wound healing and probing depth were assessed. Radiographically the changes in density, bone formation characteristics, and bone level were evaluated. The observers were blinded for the surgical procedure and follow-up duration. The study protocol was approved by Institutional Ethics Committee and registered with National clinical trial registry. Results: Wound healing was uneventful in all 24 extraction sites of 12 patients. Trabecular bone pattern with increased bone density was observed indicating complete bone healing in the graft group at third month. Probing depth was gradually decreased over a follow-up period and remained within normal limits during the third-month follow-up. These changes in the graft group were significant compared to the control group. The grafting with eggshell-derived nano-hydroxyapatite showed better bone regeneration properties without any infection or undue reactions. Conclusion: Eggshell-derived nano-hydroxyapatite showed enhancement of bone regeneration compared to the control group. Grafting maintained bone height and prevented periodontal problem emergence. Eggshell-derived nano-hydroxyapatite is a safe synthetic graft substitute because it is derived from eggshell without any diseases transfer risks, unlike allografts. The process of preparation is environment-friendly. The beneficial effects of eggshell-derived nano-hydroxyapatite may be extrapolated to develop an ideal economic graft substitute. [ABSTRACT FROM AUTHOR]

Background: Accurate identification of acute stroke by Emergency Medical Dispatchers (EMD) is essential for timely and purposeful deployment of Emergency Medical Services (EMS), and a prerequisite for operating mobile stroke units. However, precision of EMD stroke recognition is currently modest. Aims: We sought to identify targets for improving dispatcher stroke identification. Methods: Dispatch codes and EMS patient records were cross-linked to investigate factors associated with an incorrect dispatch code in a prospective observational cohort of 625 patients with a final diagnosis of acute stroke or transient ischemic attack (TIA), transported to our stroke center as candidates for recanalization therapies. Call recordings were analyzed in a subgroup that received an incorrect low-priority dispatch code indicating a fall or unknown acute illness (n = 46). Results: Out of 625 acute stroke/TIA patients, 450 received a high-priority stroke dispatch code (sensitivity 72.0%; 95% CI, 68.5–75.5). Independent predictors of dispatcher missed acute stroke included a bystander caller (aOR, 3.72; 1.48–9.34), confusion (aOR, 2.62; 1.59–4.31), fall at onset (aOR, 1.86; 1.24–2.78), and older age (aOR [per year], 1.02; 1.01–1.04). Of the analyzed call recordings, 71.7% revealed targets for improvement, including failure to recognize a Face Arm Speech Time (FAST) test symptom (21/46 cases, 18 with speech disturbance), or failure to thoroughly evaluate symptoms (12/46 cases). Conclusions: Based on our findings, efforts to improve dispatcher stroke identification should primarily focus on improving recognition of acute speech disturbance, and implementing screening of FAST-symptoms in emergency phone calls revealing a fall or confusion. Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02145663. [ABSTRACT FROM AUTHOR]

The aim of this study was to explore the methods, reporting and transparency of clinical trials in orthodontics and compare them to the field of periodontics, as a standard within dentistry. Cross-sectional bibliographic study A total of 300 trials published in 2017–2018 and evenly distributed in orthodontics and periodontics were selected, assessed and analysed statistically to explore key aspects of the conduct and reporting of orthodontic clinical trials compared to trials in periodontics. Several aspects are often neglected in orthodontic and periodontic trials and could be improved upon, including use of statistical expertise (22.3% of assessed trials), blinding of outcome assessors (62.3%), prospective trial registration (12.0%), adequate sample size calculation (35.7%), adherence to CONSORT (14.3%) and open data sharing (4.3%). The prevalence of statistically significant findings among orthodontic and periodontic trials was 62.3%, which was significantly associated with several methodological traits like statistician involvement (odds ratio [OR] = 0.5; 95% confidence interval [CI] = 0.3–0.9), blind outcome assessor (OR = 0.5; 95% CI = 0.2–1.0), lack of prospective trial registration (OR = 2.8; 95% CI = 1.3–5.9) and non-adherence to CONSORT (OR = 4.5; 95% CI = 1.3–15.8). Although trials in orthodontics seem to be significantly worse compared to periodontics in aspects like trial registration, adherence to CONSORT and declaration of competing interests or financial support, their methods do seem to have improved considerably in recent years. [ABSTRACT FROM AUTHOR]

The article reports a study which determining publication rates of randomized controlled trials in sports medicine that have been registered with ClinicalTrials.gov (CTG). The results revealed that 58 percent of sports medicine trials registered on CTG were published in a peer-reviewed journal within at least 32 months from study completion. A discrepancy was found in methodological variables including primary and secondary outcomes, eligibility criteria, and sample size requirements.

The author discusses the importance of trial registration and publication. He informs that the ClinicalTrials.gov registry was launched to assist desperate patients in locating a therapeutic study that might address their own condition. He cites a study by Chahal and colleagues that examines the publication status of sports medicine. According to the author, Public dissemination of the results of clinical trials is vital to maintaining the integrity of the medical database.

Failed research can function as the underbelly of all qualitative research projects that come to fruition. These shadow projects offer invaluable insights to future research and researchers alike. In this article, I trace a failed life history of sex offenders project from its conceptualization to its abandonment, after conducting a series of searches on the online National Sex Offender Registry database. Through the use of preliminary field notes and an analysis of media representations, I examine the role of bracketing of the topic, as a by-product of the phenomenological tradition, and other methodological issues such as physical and emotional vulnerability as a lone researcher, preconceptions harbored about "challenging" populations, and how a research setting can contribute to failed research. [ABSTRACT FROM AUTHOR]

The article presents the authors' opinion regarding the clarity and transparency needed when reporting health research. The question is raised of whose responsibility it is to improve the quality of biomedical research. The importance of maintaining clear and transparent health reporting is also discussed, noting that inadequate reporting can lead to incorrect assumptions, missed findings, and false outcomes.

An introduction is presented in which the editor discusses an assessment of randomized controlled clinical trials in leading dental journals by V. Smaïl-Faugeron and colleagues and mentions the journal will require all submitted studies have a priori clinical trial registration.